MAUDE Adverse Event Report: INVAMEX T4/WD28/HD/ADULT/28/BH16/AT903/U2222C/U67 9153653568; WHEELCHAIR, MECHANICAL

Model Number T422RDAP

Device Problems Break (1069); Out-Of-Box Failure (2311); Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

Dealer states the frame was bent right out of the box.He states the frame is damaged and that the chair arrived dirty as if it had been opened before.No further information provided.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Frame, bent frame.Bent seat rails won't fit h blocks.Product received expanded evaluation.The expanded evaluation report states: visual inspection- both of the seat rails were slightly bent inwards and therefore, did not settle into the h-block.Conclusions- utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the bent seat rails.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Frame, bent frame.Bent seat rails won't fit h blocks.Product received expanded evaluation.The expanded evaluation report states: visual inspection- both of the seat rails were slightly bent inwards and therefore, did not settle into the h-block.Conclusions- utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the bent seat rails.Dealer states the frame was bent right out of the box.He states the frame is damaged and that the chair arrived dirty as if it had been opened before.No further information provided.

• Brand Name: T4/WD28/HD/ADULT/28/BH16/AT903/U2222C/U67 9153653568
• 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: 4738883
• MDR Text Key: 5774180
• Report Number: 9616091-2015-01235
• 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,distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T422RDAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2015
• 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