MAUDE Adverse Event Report: INVAMEX TRSX5RC/WD86/28/R/AT903/U2222C/U550 9153653576; WHEELCHAIR, MECHANICAL

Model Number TRSX5RC8P

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No end user information provided.The product was returned for evaluation, and upon initial inspection, the complaint was verified.The failure mode was determined to be a broken weld on the right side at the hand grip.However, the expanded evaluation still needs to be completed.Should additional information become available, a supplemental record will be filed.

Event Description

The chair was delivered with concealed freight damage and there is a break on the back cane of the chair at the weld.

• Brand Name: TRSX5RC/WD86/28/R/AT903/U2222C/U550 9153653576
• 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: 4945168
• MDR Text Key: 23016109
• Report Number: 9616091-2015-01927
• 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
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX5RC8P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• 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