MAUDE Adverse Event Report: INVAMEX TRSX5/WD86/ADULT/18FB/BH16/1255/U2222C/U240 9153653565; 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 for the patient, a supplemental record will be filed.

Event Description

This chair arrived with a bent frame - the seat cannot be locked.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that both of the seat rails were bent inward, causing the seat rails not to settle into the h-blocks properly, which confirmed the original complaint issue.Additionally, the seat upholstery was also sagging in the middle due to the bent seat rails.

Event Description

This chair arrived with a bent frame ¿ the seat cannot be locked.

• Brand Name: TRSX5/WD86/ADULT/18FB/BH16/1255/U2222C/U240 9153653565
• 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: 5194396
• MDR Text Key: 30466816
• Report Number: 9616091-2015-02614
• 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: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• 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: 11/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2015
• 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