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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BEDS BY GEORGE BEDS BY GEORGE STD-SIDE, FULL SIZE, MANUAL HEAD ADJUST SAFETY BED

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BEDS BY GEORGE BEDS BY GEORGE STD-SIDE, FULL SIZE, MANUAL HEAD ADJUST SAFETY BED Back to Search Results
Model Number 2500
Device Problem Defective Component (2292)
Patient Problem Physical Entrapment (2327)
Event Date 07/10/2019
Event Type  malfunction  
Manufacturer Narrative
Replacement mattress that was confirmed to be built to spec was ordered and shipped to dealer who delivered it to the end user. Fda audit prompted an internal audit of warranty claims. Upon review of this claim, it was determined that an mdr should have been submitted initially which prompted this mdr to be submitted immediately.
 
Event Description
The mom of the user of the bed reported to the dealer that her daughter had gotten stuck in the bed due to the mattress not fitting tightly enough in the frame. The mom did not report any injury or damage to her daughter, she just reported that her daughter had gotten stuck in the bed. An investigation done by manufacturer and dealer showed that the mattress was undersized by the mattress vendor, which is what led to the gap. The family was advised to discontinue use of the bed until a replacement mattress, that was within spec, could be ordered and shipped to them. A replacement mattress that was within spec was ordered and shipped to the dealer who then delivered it to the family's home.
 
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Brand NameBEDS BY GEORGE
Type of DeviceSTD-SIDE, FULL SIZE, MANUAL HEAD ADJUST SAFETY BED
Manufacturer (Section D)
BEDS BY GEORGE
1045 n. nappanee street
elkhart IN 46514
Manufacturer (Section G)
BEDS BY GEORGE
1045 n. nappanee street
elkhart IN 46514
Manufacturer Contact
caleb tipton
1045 n. nappanee street
elkhart, IN 46514
5743332310
MDR Report Key8960136
MDR Text Key194634465
Report Number3008830652-2019-00002
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 Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 09/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2500
Device Catalogue Number2500
Device Lot NumberHAUPT 121318-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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