MAUDE Adverse Event Report: HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD DRIVE; SEMI ELECTRIC BED

Model Number	15030BV-HR
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	Laceration(s) (1946); Hip Fracture (2349)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a bed.The unit was not returned for evaluation.We will submit a follow-up report when additional information is available.The device had a crack in the footboard.The user has diabetes and cut her leg on the foot board.The device is also leaning on the left side.While asleep the user fell out and fractured her hip.She has had medical attention.She is in a hypo chamber for the laceration due to the diabetes.

• Brand Name: DRIVE
• Common Device Name: SEMI ELECTRIC BED
• Manufacturer (Section D): HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD; no.1 dunli ro,renhe st; yuhang,, hangzhou ,3111 07; CH ,311107
• MDR Report Key: 12678163
• Report Number: 2438477-2021-00056
• Device Sequence Number: 19134201
• Product Code: FNL
• UDI-Device Identifier: 00822383211534
• UDI-Public: 822383211534
• Combination Product (Y/N): N
• 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): 10/21/2021
• Report Date (Section F): 10/20/2021

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: Lay User/Patient
• Device Model Number: 15030BV-HR
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/13/2021
• Device Age: 4 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2021
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 108
• Date Report Sent to FDA: 10/20/2021