MAUDE Adverse Event Report: UNKNOWN NON AC-POWERED PATIENT LIFT; 880.5510

Model Number RPL450-2

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Consumer states stitching on sling is coming apart.

• Brand Name: NON AC-POWERED PATIENT LIFT
• Type of Device: 880.5510
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: patricia medina ; one invacare way; elyria, OH 44035 ; 9999999999
• MDR Report Key: 3572496
• MDR Text Key: 20010854
• Report Number: 1525712-2014-00212
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RPL450-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other