FDA Adverse Event Malfunction Summary report: N

POWERED WHEELCHAIR

MDR report key: 2874708 · Received December 15, 2012

Report

Report Number: 1525712-2012-03030
Event Type: Malfunction
Date Received: December 15, 2012
Report Date: December 14, 2012
Manufacturer: UNKNOWN
Product Code: ITI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M51PSEMIBLUE, SERIAL NUMBER/DATE CODE IS UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1125085 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 M51PSEMIBLUE POWER WHEELCHAIR RIGHT MOTOR WAS JERKING AND INTERMITTENTLY DISPLAYING A 3 FLASH CODE. THERE WAS NO PATIENT INJURY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	POWERED WHEELCHAIR	890.3860	ITI	UNKNOWN	M51PSEMIBLUE

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other