MAUDE Adverse Event Report: HANDICARE USA INC UNIVERSAL DISPOSABLE SLING; NON-AC-POWERED PATIENT LIFT

Model Number 547060MX120220

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2020

Event Type  malfunction  

Event Description

Sling is missing one of the straps that attaches to lift.If patient lifted without all 6 straps secured, patient could potentially fall out of lift.

• Brand Name: UNIVERSAL DISPOSABLE SLING
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): HANDICARE USA INC; 10888 metro ct; maryland heights MO 63043
• MDR Report Key: 10024067
• MDR Text Key: 189866187
• Report Number: 10024067
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 547060MX120220
• Device Catalogue Number: D26569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1