FDA Adverse Event Malfunction Summary report: N

GOBED II MED/SURG BED

MDR report key: 3130320 · Received May 24, 2013

Report

Report Number
0001831750-2013-04750
Event Type
Malfunction
Date Received
May 24, 2013
Date of Event
April 30, 2013
Report Date
April 30, 2013
Manufacturer
STRYKER MEDICAL-KALAMAZOO
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NC, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THERE WAS NO ISSUE WITH A DAMAGED POWER CONNECTOR, BUT THAT THE POWER CORD WAS MISSING. THIS IS NOT LIKELY TO HARM THE PATIENT BECAUSE IT WOULD BE CLEAR TO THE USER WHY BED FUNCTIONS WOULD BE UNAVAILABLE NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WERE TO RECUR.

Description of Event or Problem · 1

IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE POWER CONNECTOR WAS DAMAGED. 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 VIA REPAIR WORK ORDER THAT THE POWER CORD WAS MISSING. 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
232104 GOBED II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

Patients

Seq Age Sex Outcome Treatment
1