MAUDE Adverse Event Report: INVAMEX TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553; WHEELCHAIR, MECHANICAL

Model Number TREX20RFP

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

The complaint was confirmed from pictures provided by the dealer.The pictures show that the left seat rail is bent inward and does not rest in the front h-block.However, the underlying cause could not be determined after reviewing the documentation in this investigation.Should additional information become available, a supplemental record will be filed.

Event Description

Dealer states the seat rail is bent.

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 the chair was returned in new condition with bent seat rails that would not fit into the h-blocks, which confirmed the original complaint issue.The underlying cause was due to freight/packaging issues.There was no malfunction of the device, and there is no allegation of a serious injury or death; therefore, this is no longer an fda reportable event.

Event Description

Dealer states the seat rail is bent.

• Brand Name: TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553
• 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: 5852972
• MDR Text Key: 51360689
• Report Number: 9616091-2016-01151
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TREX20RFP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 08/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• 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