MAUDE Adverse Event Report: INVAMEX INVACARE TRACER IV HEAVY-DUTY WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number	T422RDAP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dealer advised that there was no patient involvement; the chair was being moved either up or down some stairs and was unoccupied when the weld broke.The patient weighs 341 pounds, which is below the chair's weight capacity of 450 pounds.The chair's maintenance history is unknown.As far as the dealer knows, the patient did not notice any cracks or signs of impending failure of the weld.At this time, the underlying cause of the broken weld is unconfirmed.A capa has been opened to investigate this malfunction.Should additional information become available, a supplemental record will be filed.
Event or Problem Description
The dealer reported that the frame of the t422rdap wheelchair broke where the bolt goes through the bottom mount.Pictures were provided showing that the lower axle lug, where the wheel attaches, has broken off the upright rear tube portion of the left side frame at the weld.

• Brand Name: INVACARE TRACER IV HEAVY-DUTY WHEELCHAIR
• Common Device Name: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 19772763
• Report Number: 9616091-2024-00012
• Device Sequence Number: 8068635
• Product Code: IOR
• UDI-Device Identifier: 00841447103035
• UDI-Public: 00841447103035
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2024

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 Model Number: T422RDAP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown