MAUDE Adverse Event Report: XIAMEN WORLD GEAR SPORTS GOODS CO., LTD DRIVE; BED

Model Number	PAN6300
Medical Device Problem Codes	Compatibility Problem (2960); Device Handling Problem (3265)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	11/28/2022
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bariatric bed by a distributor, who stated that "the end user had been found deceased with their head caught in the frame of the bed." drive investigated the incident and determined that there were no bed rails or handles on the bed; that the end user's head was stuck between the deck and the base of the bed at the foot section; that the facility where the end user lived had attached a bed control pendant from a different model bed; and that said bed control pendant did not operate properly with the bed in question, with several buttons not operating at all.Drive also learned that the patient was not in bed at the time of the incident, but was rather on the floor, potentially trying to retrieve an item that had fallen behind the bed, and potentially attempted to use the incompatible bed pendant to make it easier for him to reach the item.

• Brand Name: DRIVE
• Common Device Name: BED
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; xiamen world gear sports goods; 27-29 north 2nd road; xiamen, fujian 36102 2; CH 361022
• MDR Report Key: 16096589
• Report Number: 2438477-2022-00120
• Device Sequence Number: 17805286
• Product Code: FNL
• UDI-Device Identifier: 00822383008127
• UDI-Public: 00822383008127
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2023
• Report Date (Section F): 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: PAN6300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/05/2022
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/04/2022