MAUDE Adverse Event Report: SHANGHAI SHUNLONG PHYSICAL THERAPY DRIVE; BED, FULL ELECTRIC

Model Number	15300
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, (b)(6) healthcare was notified of an incident regarding a full electric bariatric bed.The end user reported that the "head will not go up and the bed will not come down when raised," and that she is currently in the hospital with bed sores that she developed when the bed was not working properly.Drive has not received any further information regarding how the bed's failure to raise and lower caused the end user's bed sores.However, drive is currently investigating the incident, including attempting to retrieve the product to inspect it.

• Brand Name: DRIVE
• Common Device Name: BED, FULL ELECTRIC
• Manufacturer (Section D): SHANGHAI SHUNLONG PHYSICAL THERAPY; 259 jiugan rd; sijing town; song jiang district, shanghai 20160 1; CH 201601
• MDR Report Key: 14105169
• Report Number: 2438477-2022-00019
• Device Sequence Number: 15010025
• Product Code: FNL
• UDI-Device Identifier: 00822383180793
• UDI-Public: 822383180793
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/13/2022
• Report Date (Section F): 04/13/2022

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: 15300
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/16/2022
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 04/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2022
• 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: Hospitalization
• Patient Sex: Female
• Patient Weight: 193 KG
• Date Report Sent to FDA: 04/13/2022