MAUDE Adverse Event Report: INVACARE TAYLOR STREET TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403; WHEELCHAIR, MECHANICAL

Model Number PROX4S

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/26/2015

Event Type  malfunction  

Event Description

Dealer advised right crossbrace is broken at a weld where seat rail meets the down tube.

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Manufacturer Narrative

The device was evaluated by the returns department which found that the cross brace was broken and there were also multiple scratches and wear marks on the tubing.

Event Description

Dealer advised right crossbrace is broken at a weld where seat rail meets the down tube.

• Brand Name: TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4936232
• MDR Text Key: 16206911
• Report Number: 1525712-2015-03994
• Device Sequence Number: 1
• Product Code: IOR
• 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,distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PROX4S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2015
• 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
• Patient Outcome(s): Other
• Patient Weight: 77