FDA Adverse Event Malfunction Summary report: N

POWERED WHEELCHAIR

MDR report key: 2912519 · Received January 12, 2013

Report

Report Number: 1525712-2013-00304
Event Type: Malfunction
Date Received: January 12, 2013
Date of Event: December 12, 2012
Report Date: January 12, 2013
Manufacturer: INVACARE TAYLOR STREET
Product Code: ITI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M91R, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY FOUR YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1141450 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 FEMALE, AND (B)(6). HOWEVER, HER AGE, AND HEIGHT 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 PATIENT OF A M91R POWER WHEELCHAIR RAISED THE ARMREST TO EXIT THE UNIT, AND UPON LOWERING THE ARMREST IT CUT THE JOYSTICK CABLE IN HALF RESULTING IN FLYING SPARKS. ADDITIONALLY, A BUTTON PLUG WAS MISSING. NO INJURY TO CONSUMER OR PROPERTY DAMAGE WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
19267	POWERED WHEELCHAIR	890.3860	ITI	INVACARE TAYLOR STREET	M91R

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other