MAUDE Adverse Event Report: NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L DRIVE; BARIATRIC BED

Model Number	15300BV-PKG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bariatric hospital bed by an end user's partner, who reported that the frame was "broken" and the end user " fell off the bed and hurt her back and bottom." he did not specify any medical treatment she received.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: BARIATRIC BED
• Manufacturer (Section D): NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L; no. 88, yangcheng road; wuyao town; rugao, jiangsu 22653 3; CH 226533
• MDR Report Key: 17139878
• Report Number: 2438477-2023-00065
• Device Sequence Number: 20277072
• Product Code: OSI
• UDI-Device Identifier: 00822383212319
• UDI-Public: 00822383212319
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Type of Report: Initial
• Report Date (Section B): 06/15/2023
• Report Date (Section F): 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 15300BV-PKG
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2023
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 06/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 193 KG
• Date Report Sent to FDA: 06/15/2023