MAUDE Adverse Event Report: XIAMEN WORLD GEAR SPORTS GOODS CO., LTD DRIVE; BED

Model Number	P703
Medical Device Problem Codes	Fire (1245); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bariatric bed by a distributor, who stated that "during operation of the bed the power cord was pinched and caused a spark, which caused a fire." given that the fire was caused by a pinched power cord, drive has confirmed that there was no reported defect or issue with the design or manufacture of the unit.There was no report or evidence of illness, injury or medical treatment associated with the complaint.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: BED
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; xiamen world gear sports goods; 27-29 north 2nd road; xiamen, fujian 36102 2; CH 361022
• MDR Report Key: 16096836
• Report Number: 2438477-2022-00121
• Device Sequence Number: 6651696
• Product Code: FNL
• UDI-Device Identifier: 00822383979434
• UDI-Public: 00822383979434
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2023
• Report Date (Section F): 01/04/2022

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
• Device Model Number: P703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/06/2022
• Device Age: 5 YR
• Date Report to Manufacturer: 01/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2023
• 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: 01/04/2022