MAUDE Adverse Event Report: INVAMEX TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL

Model Number 9TPZ

Device Problem Bent (1059)

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

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Provider states while sitting in the chair the left side wheel handrim was bent.

Manufacturer Narrative

(b)(4) 2015 - the device was returned and an initial evaluation was performed.That initial evaluation confirmed that the hand rim was bent.The item is being held for a more detailed evaluation.Should additional information become available when that evaluation is completed, a supplemental record will be filed.

Event Description

Provider states while sitting in the chair the left side wheel handrim was bent.

Manufacturer Narrative

(b)(4) 2015 - a detailed evaluation has been performed on the returned device.That evaluation confirmed the alleged issue of a bent hand rim.The evaluation also noted other minor defects, such as scratches, to the hand rims and wheels.Any underlying cause for these issues, however, were not able to be identified during the evaluation.

Event Description

Provider states while sitting in the chair the left side wheel handrim was bent.

• Brand Name: TRANSPORT 20 IN X 16 IN 9153637574
• 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: 5080459
• MDR Text Key: 26248971
• Report Number: 9616091-2015-02274
• 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
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9TPZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• 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