MAUDE Adverse Event Report: INVAMEX T4/WD08/HD/ADULT/28/BH16/AT903/U2222C/U67 9153653566; WHEELCHAIR, MECHANICAL

Model Number T420RDAP

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

Provider reported brake bushing are falling out, clothing guards broken, back upholstery is stretched out and the seat is ripped.

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Manufacturer Narrative

The device was evaluated by the returns department which found that the seat is sagging to the point of rubbing on the cross brace.Chair in very used condition.

Event Description

Provider reported brake bushing are falling out, clothing guards broken, back upholstery is stretched out and the seat is ripped.

• Brand Name: T4/WD08/HD/ADULT/28/BH16/AT903/U2222C/U67 9153653566
• 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: 4873372
• MDR Text Key: 6259550
• Report Number: 9616091-2015-01630
• 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
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T420RDAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2015
• 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