FDA Adverse Event Malfunction Summary report: N

GIRAFFE

MDR report key: 4272337 · Received November 5, 2014

Report

Report Number
4272337
Event Type
Malfunction
Date Received
November 5, 2014
Date of Event
October 31, 2014
Report Date
November 3, 2014
Manufacturer
OHMEDA MEDICAL
Product Code
FMT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
ND, US

Narratives

Description of Event or Problem · 1

THE GIRAFFE TOP OPENED TO ALLOW ACCESS TO THE INFANT DURING AN EMERGENCY. THE TOP ROSE AND THEN FELL SUDDENLY BACK ONTO THE SIDE DOORS. FOLLOWING THIS, A CLICKING/GRINDING SOUND CONTINUED UNTIL THE GIRAFFE SHUT OFF. THREE (3) STAFF MEMBERS WERE RESPONDING TO INFANT AND WERE NEAR THE COVER/SIDES OF THE GIRAFFE AT THE TIME OF THE INCIDENT. THEY WERE UNABLE TO RAISE THE TOP OF THE GIRAFFE AFTER THE INCIDENT, MAKING ACCESS TO INFANT DURING THE EMERGENCY LIMITED AND REQUIRING A MOVE OF THE PREMATURE INFANT TO A NEW GIRAFFE. THE NURSE THAT WAS CARING FOR THE INFANT HEARD A NOISE AS SHE WAS LEANING INTO THE WARMER AND SHE PULLED OUT OF THE UNIT. AS SOON AS SHE DID THAT, THE WARMER TOP DROPPED AND THE WHOLE UNIT AND THE BABY SHOOK. THE NURSES WERE VERY CONCERNED ABOUT THE INFANT AFTER THIS HAPPENED.======================MANUFACTURER RESPONSE FOR GIRAFFE WARMER OMNIBED, GIRAFFE OMNIBED (PER SITE REPORTER).======================THIS IS THE SECOND UNIT THAT THIS PROBLEM HAS HAPPENED TO. IT IS THE MAIN DRIVE ASSEMBLY THAT IS BREAKING. WE HAVE HAD GE HERE ALREADY TO REPAIR THE SAME ISSUE ON ANOTHER UNIT. THIS PROBLEM HAS HAPPENED ON 2 UNITS WITHIN A COUPLE MONTHS. GE HAS SAID THEY KNOW THERE IS A PROBLEM AND, WHEN REPLACING, ARE REPLACING THE ASSEMBLY WITH A NEW DRIVE BELT ASSEMBLY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
709908 GIRAFFE WARMER, INFANT RADIANT FMT OHMEDA MEDICAL OMNIBED NA
709909 GIRAFFE WARMER, INFANT RADIANT FMT OHMEDA MEDICAL OMNIBED NA

Patients

Seq Age Sex Outcome Treatment
1 *