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

Model Number UNKNOWN

Device Problem Material Integrity Problem (2978)

Patient Problem Pressure Sores (2326)

Event Type  No Answer Provided  

Event Description

Unknown facility reported that the end user is being treated in a hospital due to end user being given the wrong type of sling for an unknown lift.Facility stated that the physical therapist at the hospital reported that the end user got a pressure ulcer from the sling due to it not being fitted to the users needs as a quad, had to do a flap to the ulcer.Facility stated that there is nothing physically wrong with the sling, but the design was the wrong choice for the medical obstacles the patient has, user has had this sling for years.

• Brand Name: NON AC-POWERED PATIENT LIFT
• Type of Device: 880.5510
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4154934
• MDR Text Key: 15343975
• Report Number: 1525712-2014-06834
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2014

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
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 10/09/2014
• 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