FDA Adverse Event Malfunction Summary report: N

AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

MDR report key: 2843181 · Received November 21, 2012

Report

Report Number: 1031452-2012-00288
Event Type: Malfunction
Date Received: November 21, 2012
Report Date: November 20, 2012
Manufacturer: INVACARE FLORIDA OPERATIONS
Product Code: FNL
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL 5310IVC, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1114836, REV. F(AUG-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. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

Description of Event or Problem · 1

DEALER STATES MOTOR WOBBLY, SHAKES. THE REPORTER HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION. IT WAS LEARNED THAT RIGHT WHERE THE MOTOR CASING, GEAR CASING, AND SHAFT COME TOGETHER IS WHERE THE PROBLEM LIES. AT TIMES THE MOTOR WILL SURGE. NO INJURIES REPORTED. THE DEALER STILL HAS THE MOTOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS	880.5100	FNL	INVACARE FLORIDA OPERATIONS	5310IVC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other