MAUDE Adverse Event Report: HANDICARE USA, INC. HANDICARE; AP450

Model Number	AP450
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported smoke being emitted from a handicare ap450 ceiling lift.Review of the returned lift provided evidence that a heating event occurred internally to the lift.

• Brand Name: HANDICARE
• Common Device Name: AP450
• Manufacturer (Section D): HANDICARE USA, INC.; 10800 metro court; maryland heights MO 63043
• MDR Report Key: 11289739
• Report Number: 3007802293-2021-00002
• Device Sequence Number: 17004372
• Product Code: FSA
• UDI-Device Identifier: 00810045510385
• UDI-Public: 00810045510385
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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: Health Professional
• Device Model Number: AP450
• Device Catalogue Number: 303060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1