MAUDE Adverse Event Report: ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD DRIVE; BED

Model Number	15030BV-FR
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Fall (1848); Neck Pain (2433)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving an electric hospital bed by provider, who stated that "the bed bent and the [end user] fell." the end user reported neck pain, for which he is receiving physical therapy.The provider stated that there were two separate beds involved in this incident but has been unable to provide details on which bed was the reported cause of the injury.Drive is currently investigating the incident, and has followed up multiple times in attempt to gain additional information.Drive has also attempted to retrieve the product and inspect it.Drive will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: BED
• Manufacturer (Section D): ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD; no 4 and no 8 plants 9 shenghu; nantou town; zhongshan city, guangdong 51000 ; CH 51000
• MDR Report Key: 16407468
• Report Number: 2438477-2022-00138
• Device Sequence Number: 12189510
• Product Code: FNL
• UDI-Device Identifier: 00822383211527
• UDI-Public: 822383211527
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2023
• Report Date (Section F): 02/21/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 15030BV-FR
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/30/2022
• Device Age: 7 YR
• Date Report to Manufacturer: 03/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/21/2023