FDA Adverse Event Malfunction Summary report: N

POWERED WHEELCHAIR

MDR report key: 2760129 · Received September 26, 2012

Report

Report Number: 1525712-2012-01601
Event Type: Malfunction
Date Received: September 26, 2012
Report Date: September 25, 2012
Manufacturer: INVACARE TAYLOR STREET
Product Code: ITI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

MDR DECISION DATE: (B)(6) 2012 - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M91-TS SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS AND 1 MONTH OLD. THE OWNER'S MANUAL PART NUMBER 11141450, REV.E (OCT-08) 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. A CALL WAS PLACED FOR ADDITINAL INFORMATION HOWEVER, CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.THE MALFUNCTION HAS NOT BEEN CONFIRMED.

Description of Event or Problem · 1

CONSUMER WAS ON A BUS AND SHE TURNED OFF THE DEVICE OFF. "GOODBYE" CAME ON THE DISPLAY, HOWEVER, THE DEVICE WOULD NOT TURN OFF. AFTER 2.5 HOURS CHAIR TURNED OFF AND RAN NORMAL. THE REPORTER OF THE EVENT WILL NOT TURN OFF THE DEVICE. NO REPORTED INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	POWERED WHEELCHAIR	890.3860	ITI	INVACARE TAYLOR STREET	M91-TS

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other