FDA Adverse Event Malfunction Summary report: N

MECHANICAL (MANUAL) WHEELCHAIR

MDR report key: 2890385 · Received December 29, 2012

Report

Report Number: 1525712-2012-03375
Event Type: Malfunction
Date Received: December 29, 2012
Report Date: December 29, 2012
Manufacturer: INVACARE TAYLOR STREET
Product Code: IOR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL MVPS, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY SIX YEARS OLD. ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH THREE DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE NUMBERS ARE THE FOLLOWING: (B)(4). THE OWNER'S MANUAL PART NUMBER 1106638REV. B (OCT-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 CONSUMER'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

(B)(4). THE DEALER REPORTED THAT THE MVPS MECHANICAL WHEELCHAIR HAD THE CROSSBRACE BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MECHANICAL (MANUAL) WHEELCHAIR	890.3850	IOR	INVACARE TAYLOR STREET	MVPS

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other