MAUDE Adverse Event Report: INVAMEX TRSX5RC/WD66/28/R/U240 9153641587; WHEELCHAIR, MECHANICAL

Model Number TRSX5RC

Device Problems Bent (1059); Positioning Problem (3009)

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

Dealer is stating that the cross brace is bent causing the seat to not sit correctly on the frame.

Manufacturer Narrative

Visual inspection: the right and left seat rails were bent inward resulting in excessive sag in the seat upholstery.The right and left seat rails were misaligned with the h-blocks.Conclusions: the complaint was confirmed for the wheelchair having bent seat rails causing the seat to not align into the h-blocks.

Event Description

Per the returns expanded evaluation report form, it is confirmed that the seat rails are bent causing the seat to not align into the h-blocks causing the seat to sag.

• Brand Name: TRSX5RC/WD66/28/R/U240 9153641587
• 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: 4929186
• MDR Text Key: 22463103
• Report Number: 9616091-2015-01875
• 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: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX5RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• 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