MAUDE Adverse Event Report: HANDICARE USA INC. C450 MANUAL TRAVERSE; CEILING LIFT

Model Number	323100
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754); Fall (1848)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was about to be transported when the ceiling track and lift fell from the ceiling.The patient fell onto his bed and received two scratches and a bruise.
Additional Manufacturer Narrative
This investigation is ongoing.A follow-up report will be submitted when complete.

• Brand Name: C450 MANUAL TRAVERSE
• Common Device Name: CEILING LIFT
• Manufacturer (Section D): HANDICARE USA INC.; 10888 metro ct.; maryland heights MO 63043
• MDR Report Key: 12241766
• Report Number: 3007802293-2021-00008
• Device Sequence Number: 4447784
• Product Code: FSA
• UDI-Device Identifier: 00810045510057
• UDI-Public: 00810045510057
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: Health Professional
• Device Model Number: 323100
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/28/2021
• 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