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

Model Number	PLTCABL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Strangulation (2084)
Date of Event	01/03/2024
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a long-term care assist bar by the cpsc.The cpsc forwarded a redacted coroner's report, which stated that an end-user was discovered deceased in his room at a long-term care facility with his head and neck entrapped between the assist bar and the hospital bed mattress.The cause of death was determined by the coroner to be "asphyxia due to strangulation." the coroner's report did not provide any information regarding how the assist bar was installed at the time of the incident, or the specifications of the mattress being used with the bed and assist bar.Drive devilbiss healthcare has contacted the coroner's office for further information.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this incident.

• Brand Name: DRIVE
• Common Device Name: BARIATRIC BED
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; 27-29 north 2nd road; xiamen, fujian 36102 2; CH 361022
• MDR Report Key: 19395759
• Report Number: 2438477-2024-00028
• Device Sequence Number: 20571712
• Product Code: OSI
• UDI-Device Identifier: 00822383979540
• UDI-Public: 00822383979540
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024
• Report Date (Section F): 05/24/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: PLTCABL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/30/2024
• Event Location: Other
• Date Report to Manufacturer: 05/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• 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 Age: 88 YR
• Patient Sex: Male
• Date Report Sent to FDA: 05/24/2024