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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUBBYBED / BETTER SLEEP DESIGNS LLC. CUBBY BED BED, MANUAL

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CUBBYBED / BETTER SLEEP DESIGNS LLC. CUBBY BED BED, MANUAL Back to Search Results
Device Problem Collapse (1099)
Patient Problem Loss of consciousness (2418)
Event Date 06/15/2021
Event Type  Death  
Event Description
Cubby bed, approved by fda for safe sleep for wandering sleepers with special needs, as a safe place for sleep. The design of the bed and cover allows for a space that caused entrapment and resulted in this death. Child was put down for a nap, found unconscious and unresponsive by parents, trapped between the mattress and the cover of the bed. Resuscitation efforts were unsuccessful. Fda safety report id # (b)(4).
 
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Brand NameCUBBY BED
Type of DeviceBED, MANUAL
Manufacturer (Section D)
CUBBYBED / BETTER SLEEP DESIGNS LLC.
MDR Report Key12318404
MDR Text Key266401838
Report NumberMW5103228
Device Sequence Number1
Product Code FNJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/13/2021 Patient Sequence Number: 1
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