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

Model Number TREXD28R

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

The caller states that the seat is sagging and needs to be replaced.

Manufacturer Narrative

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

• Brand Name: TRANSPORT 20 IN X 16 IN 9153637574
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4786966
• MDR Text Key: 21769961
• Report Number: 1525712-2015-03025
• Device Sequence Number: 1
• Product Code: FSA
• 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
• Type of Report: Initial
• Report Date: 04/16/2015

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 Operator: Lay User/Patient
• Device Model Number: TREXD28R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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