MAUDE Adverse Event Report: HANDICARE USA, INC. C625 LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number C-625

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2022

Event Type  malfunction  

Event Description

Lift not working in patient room, is able to go down but stops frequently when attempting to lift patient.

• Brand Name: C625 LIFT
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): HANDICARE USA, INC.; 10888 metro ct.; maryland heights MO 63043
• MDR Report Key: 15232432
• MDR Text Key: 297999576
• Report Number: 15232432
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-625
• Device Catalogue Number: PRODUCT PART #: 11011853
• Device Lot Number: C6M0015481
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1