MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO., LTD DRIVE; ELECTRIC BED

Model Number	15030
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Limb Pain (4836)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint involving a bedrail by the end user's son, who reported that his father "has alzheimer's and is injuring his arms by putting him through the rails," and that he believes the manufacturer should "provide the pads to keep this from happening." it is unclear what pads to which the reporter referred, and there was no further information provided regarding the specifics or severity of the reported injury.Drive is currently investigating the complaint, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ELECTRIC BED
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO., LTD; no.386-3 qingnian st; heping dis.; shenyang, liaoning 11000 4; CH 110004
• MDR Report Key: 16940773
• Report Number: 2438477-2023-00034
• Device Sequence Number: 7375131
• Product Code: FNL
• UDI-Device Identifier: 00822383111094
• UDI-Public: 00822383111094
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/16/2023
• Report Date (Section F): 05/16/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 15030
• Device Catalogue Number: 15030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/15/2023
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 05/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2023
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Date Report Sent to FDA: 05/16/2023