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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BEDS BY GEORGE BED BY GEORGE DREAM SERIES FULL SIZE HIGH-SIDE SAFETY BED WITH CANOPY BED MANUAL

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BEDS BY GEORGE BED BY GEORGE DREAM SERIES FULL SIZE HIGH-SIDE SAFETY BED WITH CANOPY BED MANUAL Back to Search Results
Model Number 2700
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Physical Entrapment (2327)
Event Date 04/12/2019
Event Type  Injury  
Event Description
Consumer was placed in her beds by george full sized dream series 2700 safety bed for sleep as usual. She had been sleeping in the new bed since it was delivered mid (b)(6) 2019. About 0530 in the morning, mom heard a repetitive sound like someone was kicking a door. Went to investigate where it was coming from. Ended up across the hall in (b)(6) room. Looked in her safety bed and she was not visible. Upon closer inspection, the mattress appeared elevated. The kicking sound was still being heard. Mom released the side rail and found (b)(6) awake and underneath the mattress. (b)(6) climbed out with assistance. No visible injuries. She was fully awake and conscious. Notified beds by george employee (b)(6). (b)(6) requested bed measurements and extensive photographs. He refused to send a beds by george employee in person to look at the bed when parents requested it. He determined solely from photographs that the mattress was too small for the bed frame and needed to be medical grade foam not innerspring. (b)(6) stated that a new custom-sized (larger) medical-grade foam mattress would be sent to consumer's home asap and within the week. Two weeks have passed and no replacement mattress received to date. Entrapment of consumer. Fda safety report id# (b)(4).
 
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Brand NameBED BY GEORGE DREAM SERIES FULL SIZE HIGH-SIDE SAFETY BED WITH CANOPY
Type of DeviceBED MANUAL
Manufacturer (Section D)
BEDS BY GEORGE
MDR Report Key8569260
MDR Text Key143937925
Report NumberMW5086300
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2700
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 04/30/2019 Patient Sequence Number: 1
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