FDA Adverse Event Malfunction Summary report: N

POWERED WHEELCHAIR

MDR report key: 2832844 · Received November 14, 2012

Report

Report Number: 1525712-2012-02170
Event Type: Malfunction
Date Received: November 14, 2012
Report Date: November 12, 2012
Manufacturer: INVACARE TAYLOR STREET
Product Code: ITI
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL R51LXP, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 9 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1106645 REV.G (JUL-07) 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. MALFUNCTION HAS NOT BEEN CONFIRMED.

Description of Event or Problem · 1

(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES LEFT REAR ARM SOCKET HAS TOO MUCH PLAY OR ALIGNMENT ISSUE WHEN FLIPPING BACK AND THEN FLIPPING FORWARD. WILL NOT GO INTO THE FRONT SOCKET EASILY, DUE TO NOT STOPPING AT THE PROPER PLACE, HAVE TO MANEUVER IT PHYSICALLY TO INSERT FRONT PART OF ARM TO FRONT SOCKET. MDR FILED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	POWERED WHEELCHAIR	890.3860	ITI	INVACARE TAYLOR STREET	R51LXP

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other