MAUDE Adverse Event Report: INVAMEX T4/WD28/HD/ADULT/18/BH16/AT903/U2222C/U67 9153653569; WHEELCHAIR, MECHANICAL

Model Number T420RFA

Device Problem Break (1069)

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

The provider states the rear weld by the anti tipper broke on the left side.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.Per the initial evaluation, the weld/tubing at the bottom rear of the left side frame was broken.An expanded evaluation was performed.The expanded evaluation report confirmed that the side frame had a broken weld at the bottom of the back cane.Additionally, there were several areas with paint loss and corrosion.Therefore, the complaint was confirmed, but the underlying cause could not be determined.

Event Description

The provider states the rear weld by the anti tipper broke on the left side.

• Brand Name: T4/WD28/HD/ADULT/18/BH16/AT903/U2222C/U67 9153653569
• 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: 5307945
• MDR Text Key: 34353262
• Report Number: 9616091-2015-02929
• 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: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T420RFA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• 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