MAUDE Adverse Event Report: INVAMEX T4/WD28/HD/ADULT/28/BH16/AT903/U2222C/COM/U550 9153639572; WHEELCHAIR, MECHANICAL

Model Number T422RDA

Device Problem Material Separation (1562)

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

On the right and the left frame where the back cane is welded to the frame the weld has came apart.

Manufacturer Narrative

Additional/updated information was added to reflect the right and left side frames being returned to the manufacturer for evaluation, and subsequent testing verified the complaint.Per the initial evaluation, they both had a broken weld/tubing at the bottom rear of the frame.An expanded evaluation was performed.The expanded evaluation report confirmed that both side frames had broken welds at the bottom of the back canes.However, the underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

On the right and the left frame where the back cane is welded to the frame the weld has came apart.

• Brand Name: T4/WD28/HD/ADULT/28/BH16/AT903/U2222C/COM/U550 9153639572
• 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: 5809175
• MDR Text Key: 50340504
• Report Number: 9616091-2016-01101
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T422RDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2016
• 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