FDA Adverse Event Malfunction Summary report: N

POWERED WHEELCHAIR

MDR report key: 2802297 · Received October 23, 2012

Report

Report Number: 1525712-2012-01940
Event Type: Malfunction
Date Received: October 23, 2012
Date of Event: October 3, 2012
Report Date: October 23, 2012
Manufacturer: INVACARE TAYLOR STREET
Product Code: ITI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL M51, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 7 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1125085, REV.J(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. IT HAS ALSO BEEN REPORTED BY A TECHNICIAN FOR EVALUATION AND IT WAS THOUGHT SHE MAY NOT HAVE ENOUGH WEIGHT FOR THIS DEVICE. A REPLACEMENT DEVICE HAS BEEN SENT. IF ANY FURTHER DETAIL IS OBTAINED REGARDING THE INCIDENT A FOLLOW UP REPORT WILL BE FILED. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

Description of Event or Problem · 1

A REPORT WAS RECEIVED ON AN EVENT OF THE DEVICE VEERING TO THE LEFT. THE REPORTER HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION. IT WAS LEARNED SHE REPORTEDLY SHE HIT HER HEAD ON THE WALL AND BRUISED HER ARM. IT WAS LEARNED SHE DID NOT RECEIVE ANY MEDICAL INTERVENTION. INCIDENT OCCURRED IN HOUSE AND SHE HAS BEEN ISSUED A REPLACEMENT WHEELCHAIR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	POWERED WHEELCHAIR	890.3860	ITI	INVACARE TAYLOR STREET	M51

Patients

Seq	Age	Sex	Outcome	Treatment
1	69		Other