FDA Adverse Event Injury Summary report: N

POWERED WHEELCHAIR

MDR report key: 2862496 · Received December 10, 2012

Report

Report Number: 1525712-2012-02749
Event Type: Injury
Date Received: December 10, 2012
Report Date: December 6, 2012
Manufacturer: INVACARE TAYLOR STREET
Product Code: ITI
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HI, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL R32LX, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 8 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1106644 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

DEALER STATES WHEEL CAME OFF OF CHAIR AND PATIENT FELL OUT OF CHAIR. IT WAS LEARNED THAT AN INJURY HAD OCCURRED HOWEVER NO FURTHER DETAIL OR INFORMATION HAD BEEN PROVIDED. THEREFORE UNTIL FURTHER CLARIFICATION IS RECEIVED THE INCIDENT IS BEING FILED AS A SERIOUS INJURY. PLEASE NOTE ANY FURTHER INFORMATION OR DEVICE EVALUATION WILL BE PROVIDED IN A FOLLOW UP REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	POWERED WHEELCHAIR	890.3860	ITI	INVACARE TAYLOR STREET	R32LX

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other