FDA Adverse Event Malfunction Summary report: N

MECHANICAL (MANUAL) WHEELCHAIR

MDR report key: 2802235 · Received October 23, 2012

Report

Report Number: 9616091-2012-00456
Event Type: Malfunction
Date Received: October 23, 2012
Report Date: October 21, 2012
Manufacturer: INVAMEX
Product Code: IOR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TREX2OR, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY TWO YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1110546 REV. F (AUG-10), WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUME'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

Description of Event or Problem · 1

ON (B)(6) - IT WAS REPORTED BY THE CONSUMER THAT THE TREX2OR MECHANICAL WHEELCHAIR AFTER GOING UP A GRADE ON THE ROAD THE RIGHT FRONT CASTER GOT BENT , MAKING IT UNABLE TO PUSH THE CHAIR NORMALLY, BUT HAVING TO TILT THE CHAIR BACK AND PUSH IT ON THE BACK WHEELS. ADDITIONALLY, BOTH BACK WHEELS FELT A LITTLE WOBBLY. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MECHANICAL (MANUAL) WHEELCHAIR	890.3850	IOR	INVAMEX	TREX2OR

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other