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

Model Number TRSX5

Device Problems Bent (1059); Out-Of-Box Failure (2311)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dealer advised both crossbraces bent out the box.

Manufacturer Narrative

Per the technician's evaluation, the seat rails are both bent.These are new out of the box, both have freight damage.

Event Description

Per the technician's evaluation, the seat rails are both bent.These are new out of the box, both have freight damage.Dealer advised both crossbraces bent out the box.

• Brand Name: TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5235863
• MDR Text Key: 31802714
• Report Number: 9616091-2015-02752
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2016
• 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