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

Model Number	15037MN
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bed motor and hand control by an end user's daughter, who stated that "her mother was trying to use the hand control to move the bed and sparks started coming from the motor/wire the hand control connects to." there was no report or evidence of illness, injury or medical treatment associated with the complaint.They unplugged the unit.No one was harmed and the fire was only on the motor/wires." the product was never returned for evaluation.

• Brand Name: DRIVE
• Common Device Name: BED MOTOR
• Manufacturer (Section D): HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD; no.1 dunli road; renhe street; yuhang, hangzhou 31110 7; CH 311107
• MDR Report Key: 15738334
• Report Number: 2438477-2022-00103
• Device Sequence Number: 19560139
• Product Code: FNL
• UDI-Device Identifier: 00822383180328
• UDI-Public: 822383180328
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 11/03/2022
• Report Date (Section F): 11/03/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 15037MN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/28/2021
• Device Age: 5 YR
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 11/03/2022