MAUDE Adverse Event Report: INVACARE CLEVELAND STREET INVACARE MATRX PERSONAL BACK10 TALL 16 WIDE 9153652439; CUSHION, WHEELCHAIR

Model Number PBT16

Device Problems Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The underlying cause could not be determined however the issue was confirmed for a cracked seat shell.Mdr is being submitted as a result of a retrospective complaint review.

Event Description

The back is cracked and the hardware is broken as well.

• Brand Name: INVACARE MATRX PERSONAL BACK10 TALL 16 WIDE 9153652439
• Type of Device: CUSHION, WHEELCHAIR
• Manufacturer (Section D): INVACARE CLEVELAND STREET; 899 cleveland street; elyria OH 44036
• Manufacturer (Section G): INVACARE CLEVELAND STREET; 899 cleveland street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5752016
• MDR Text Key: 48578860
• Report Number: 1219590-2016-00114
• 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: 05/04/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PBT16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2012
• Was Device Evaluated by Manufacturer?: Yes
• 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