FDA Adverse Event Malfunction Summary report: N

GOBED II MED/SURG BED

MDR report key: 3170845 · Received June 14, 2013

Report

Report Number
0001831750-2013-05451
Event Type
Malfunction
Date Received
June 14, 2013
Date of Event
May 20, 2013
Report Date
May 20, 2013
Manufacturer
STRYKER MEDICAL-KALAMAZOO
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS. FURTHER INVESTIGATION DETERMINED THERE WAS AN ISSUE WITH THE SCALE BEING INACCURATE AND NOT THE POWER CORD AS INITIALLY REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED BY REPAIR WORK ORDER THAT THE SCALE WAS INACCURATE DUE TO A FAULTY LOAD CELLS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED BY REPAIR WORK ORDER THAT THE POWER CORD HAD TO BE REPLACED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
272228 GOBED II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

Patients

Seq Age Sex Outcome Treatment
1