MAUDE Adverse Event Report: UNKNOWN INVACARE MATRX PS CUSHION W20 X D18 9153650831; CUSHION, WHEELCHAIR

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported by dealer that the end user has a matrx pb back from a few years ago and he doesn't have order or s/n info for the chair.He stated that the right bracket on the bottom is unattached and is hanging because it has broken off.He advised her not to use the back any longer and it has not caused any injury.He believes it is the quick release hardware and he sent a picture but was advised that we could not confirm the back hardware in the picture.

• Brand Name: INVACARE MATRX PS CUSHION W20 X D18 9153650831
• Type of Device: CUSHION, WHEELCHAIR
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4346873
• MDR Text Key: 5180220
• Report Number: 1525712-2014-08774
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2014
• 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