FDA Adverse Event Malfunction Summary report: N

POWERED WHEELCHAIR

MDR report key: 2843209 · Received November 21, 2012

Report

Report Number: 3004493922-2012-00511
Event Type: Malfunction
Date Received: November 21, 2012
Date of Event: October 23, 2012
Report Date: November 21, 2012
Manufacturer: INVACARE SUZHOU
Product Code: ITI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 2 YEARS, 9 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143206, REV.G(FEB-09), 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 IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

Description of Event or Problem · 1

A DEALER HAS CALLED IN TO TECHNICAL SERVICES REGARDING A BRAKE FAULT. IT WAS REPORTED NO INJURY HAD OCCURRED. IF ANY FURTHER INFORMATION IS RECEIVED REGARDING THIS INCIDENT A FOLLOW UP REPORT WILL BE FILED. AN ATTEMPT WAS MADE TO GATHER ADDITIONAL INFORMATION BUT TO DATE, NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS FILING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	POWERED WHEELCHAIR	890.3860	ITI	INVACARE SUZHOU	M41

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other