FDA Adverse Event Malfunction Summary report: N

GOBED II

MDR report key: 2931154 · Received January 28, 2013

Report

Report Number
0001831750-2013-00415
Event Type
Malfunction
Date Received
January 28, 2013
Date of Event
January 5, 2013
Report Date
January 5, 2013
Manufacturer
STRYKER MEDICAL-KALAMAZOO
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NY, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

POWER CORD MISSING GROUND PRONG.FOWLER GAS SPRING CYLINDER.

Additional Manufacturer Narrative · 1

IT WAS INITIALLY REPORTED THAT THE BED HAD NO POWER, THE FOOT END WAS DRIFTING, AND THE FOWLER WOULDN'T LOWER. FURTHER INVESTIGATION DETERMINED THE BED HAD NO POWER DUE TO THE GROUND PRONG WAS MISSING FROM THE POWER CORD, THE FOOT END WAS DRIFTING DUE TO A FAULTY LIFT MOTOR, THE FOWLER WOULDN'T LOWER DUE TO A MISSING GAS CYLINDER, AND THE HEAD END LIFT WAS STUCK IN AN ELEVATED POSITION DUE TO A FAULTY LIFT MOTOR.

Description of Event or Problem · 1

IT WAS REPORTED BY SERVICE REPORT THAT THE GROUND PRONG WAS MISSING FROM THE POWER CORD, THE FOOT END WAS DRIFTING DUE TO A FAULTY MOTOR, THE HEAD END LIFT WAS STUCK IN AN ELEVATED POSITION DUE TO A FAULTY MOTOR. AND THE FOWLER GAS CYLINDER WAS MISSING. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED BY SERVICE REPORT THAT THE BED HAD NO POWER, THE FOOT END WAS DRIFING, AND THE FOWLER WOULDN'T LOWER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
36659 GOBED II BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

Patients

Seq Age Sex Outcome Treatment
1