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

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.

• Brand Name: BEDS BY GEORGE
• Type of Device: STD-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 Key: 8960136
• MDR Text Key: 194634465
• Report Number: 3008830652-2019-00002
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2500
• Device Catalogue Number: 2500
• Device Lot Number: HAUPT 121318-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1