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

Model Number	15033
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	07/23/2021
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare is he initial importer of the device which is a bed.The device has not been retrieved for evaluation.A follow-up report will be filed when additional information is received.While in use the inclined headboard suddenly crashed down.The service provider replaced the bed and noted that the motor was broken.The user was traumatized by the sudden movement.She did not fall out of the bed.Her spouse stated that it required two days of hourly medication to calm her down.The death is not ascribed to the incident as end-user was already in hospice care for huntington's disease.

• Brand Name: DRIVE
• Common Device Name: BED
• Manufacturer (Section D): HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD; no.1 dunli road,renhe street,; yuhang,; hangzhou, zhejiang 31110 7; CH 311107
• MDR Report Key: 12323931
• Report Number: 2438477-2021-00036
• Device Sequence Number: 16818337
• Product Code: FNL
• UDI-Device Identifier: 00822383180328
• UDI-Public: 822383180328
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/16/2021
• Report Date (Section F): 08/16/2021

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: Other
• Device Model Number: 15033
• Was the Report Sent to FDA?: Yes
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 08/20/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2021
• 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: Death
• Date Report Sent to FDA: 08/16/2021