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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations fatality reports describe a suffocation death, as follows:
A 1-month-old was found partially rolled over onto their side in a softsided compact bassinet/travel bed.
A 2-month-old infant was found completely rolled over the edge of an inbed sleeper.
A 2-month-old was placed in an inbed sleeper, in a prone position, stomach down, with his face turned to one side; he was discovered with part of his body outside the sleeper, face down into a blanket.
A 2-month-old infant was put into a compact bassinet/travel bed placed on top of an adult bed, with one side of the compact bassinet/travel bed leaning against the wall. According to the official report, the combination of the travel beds non-reinforced flexible bottom, along with the soft surface of the adult bed, allowed the infant to sink;
he was found trapped between the bed and the wall.
A 3-month-old, in a handheld basket that was placed on an adult bed, was found completely rolled over from her original supine position.
A 4-month-old was placed on his back in an in-bed sleeper that was placed inside a standard bassinet; the infant was discovered in a prone position deceased.
A 7-month-old was wrapped in a blanket and placed supine in an in-bed sleeper. The infant was found deceased, having rolled over into a prone position.
The remaining four fatalities are as follows:
A 1-month-old was placed in an inbed sleeper inside a play yard. The official reports describe the decedent as having suffocated on the puffy sides of the sleeper or becoming entrapped somehow, suffering positional asphyxia.
A 7-month-old was placed in an inbed sleeper for a nap. According to official reports, at some point, the infant got to the edge of the adult bed and became entrapped between the footboard and the mattress of the adult bed and died of positional asphyxia.
Official reports deemed the cause and manner of death for two additional fatalities as undetermined. Both decedents were 1-month-olds, one placed in a basket, while the other was in an in-bed sleeper.

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b Nonfatalities From among the 172 nonfatal reports, CPSC identified 16 injury reports associated with the use of flat sleep products that occurred between January 1, 2019 and December 31, 2020. We describe the severity of the injury type among the 16 injuries below:

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Two infants required hospital admission. An 8-day-old infant suffered unspecified breathing difficulties;
another 2-month-old infant fell out of an in-bed sleeper and suffered head injuries when a sibling jumped onto the couch where the in-bed sleeper was situated.
Ten infants, ranging in age from 1
month to 9 months, required emergency department ED visits after falling out of the sleeper product. For most cases, the sequence of events leading to each fall was unreported. In two cases, the infant fell while being transported in the sleeper; and in another case, the sleeper slipped off of the adult bed on which it was placed. The injuries included head injuries, such as a skull fracture, closedhead injury, and head contusion, or other injuries, such as face abrasion and knee contusion.
Four other injury incidents reported an allergic reaction; a mold-related breathing difficulty episode; laceration of the nose on the rough mesh wall surface on the sleeper; and a fall when a sibling pulled on the sleeper, causing it to flip over. One of these infants required repeated visits to a medical professional, but the level of care the other infants received was unspecified.
The remaining 156 incidents reported no injuries, or provided no information about any injury. However, many of the descriptions were similar to incidents in which a serious injury or death occurred. Therefore, CPSC staff indicated the potential for a serious injury or even death. Forty-nine percent of the incidents involved infants 0 to 5
months of age, and 4 percent involved infants 6 to 12 months of age. The age was unknown in 37 percent of the incidents.
2. Hazard Patterns Similar to the inclined sleep products, the hazard patterns reported for the flat sleep products varied according to the type and usage pattern of the product.
Many of the products are new in the marketplace, and consumers and safety advocates expressed concern about their safety. Staff identified the hazard patterns among the 183 reported incidents 11 fatal and 172 nonfatal associated with the use of these flat sleep products. We present the staffidentified hazard patterns below in descending order of frequency among the reports.
a Lock/Latch problems: One hundred and fifteen of the 183 reports 63 percent fall in this category. All but one of these reports pertain to different models of a particular stand-alone compact bassinet. The locking/latching mechanism that controls the opening/

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closing of the cover on the product failed. Some reports describe that the inability of the cover to open completely results in the product not lying flat. The single report about a different product describes a foldable sleeper not remaining flat; the unit reportedly folds up while the baby is in the product.
None of the reports mention any injuries.
b Comments/Concerns: Twenty-nine of the 183 reports 16 percent expressed consumers or safety advocates concerns about the perceived safety hazard of a product, non-compliance with the relevant standards for which a product is being labeled, and/or misleading marketing statements about a product. None of the reports indicate that an incident actually occurred.
c Falls/Containment issues: Twelve of the 183 incidents 7 percent report an infant falling out of the product or an infant not being kept contained within the product. Examples include infants rolling out of a sleeper onto an adult bed and then onto floor; an infant falling out of a sleeper when a sibling jumped onto the couch containing the sleeper; an infant crawling/rolling unwitnessed out of a sleeper and getting entrapped between an adult bed frame and mattress. This category includes one death, one hospital admission, and nine ED visits.
d Instability issues: Twelve of the 183 reported incidents 7 percent describe problems with the product not remaining stable. The incident reports describe some products with legs lifting up higher or leaning on one side; other products have slipped off or flipped over from the adult beds/couches on which they were resting. This category includes two reported injuries, one involving an ED visit.
e Asphyxiation/Suffocation hazard:
Nine of the 183 indents 5 percent fall into this category. The products were compact bassinets/travel beds, baskets, as well as in-bed sleepers, one being used inside a standard bassinet and another, inside a play yard. All but one of the infants had rolled over from their initial positioneither fully or partially;
positional information is not available for one infant. Eight of the incidents were fatalities due to suffocation or positional asphyxia; one was a nearsuffocation episode, with a parent nearby to rescue the infant.
f Miscellaneous product-related issues: Three of the 183 incident reports 2 percent are about mold or quality of the product material. Two of the three products were in-bed sleepers, and the third was a compact bassinet/travel bed.
All three report an injury.

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