FDA Adverse Event Malfunction Summary report: N

MECHANICAL (MANUAL) WHEELCHAIR

MDR report key: 2579429 · Received May 18, 2012

Report

Report Number: 1525712-2012-00557
Event Type: Malfunction
Date Received: May 18, 2012
Report Date: May 14, 2012
Manufacturer: INVACARE TAYLOR STREET
Product Code: IOR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TER, SERIAL NUMBER/DATE CODE IS UNKNOWN AT THIS TIME. THE OWNER'S MANUAL PART NUMBER 1122172 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 IS A (B)(6). THE CONSUMER'S PREEXISTING MEDICAL CONDITION STATES A SPINAL CORD INJURY. THE CONSUMER'S STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CONSUMER STATED THAT THE CASTERS WILL NOT STAY ON THE WHEELCHAIR. THEY BECOME STRIPPED AND FALL OFF, AN ISSUE WITH THE FORK. THE CONSUMER HAS BEEN IN A WHEELCHAIR FOR 30 YEARS, THEREFORE, HE HAS 4 SPARE WHEELCHAIRS IN HIS ATTIC WHICH HE RETRIEVES SPARE PARTS FROM. NO INJURY OR MEDICAL INTERVENTION ALLEGED. NO RMA ISSUED AT THIS TIME FOR THE RETURN OF THE CASTERS OR FORK.

Description of Event or Problem · 1

CUSTOMER ALLEGES THE CASTERS WILL NOT STAY ON THE CHAIR, THEY STRIP AND THE WHEEL FALLS OFF. NO INJURY ALLEGED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	58		Other