BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANDA IRES WARMER

    MDR report key: 4346905 · Received December 16, 2014

    Report

    Report Number
    1121732-2014-00003
    Event Type
    Injury
    Date Received
    December 16, 2014
    Date of Event
    November 14, 2014
    Report Date
    November 18, 2014
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    PMA / PMN Number
    K123309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). GE HEALTHCARE'S INVESTIGATION OF THE REPORTED EVENT IS BASED ON INFORMATION OBTAINED FROM HOSPITAL STAFF AND THE INTERNAL INCIDENT REPORT. ON (B)(6) 2014 THE PANDA WARMER WAS TAKEN TO THEATRES IN ORDER TO RECEIVE A NEWBORN INFANT FOLLOWING DELIVERY BY CAESAREAN SECTION. THE PANDA WARMER WAS CHECKED PRIOR TO USE AND BOTH CYLINDERS WERE FULL. AT DELIVERY THE BABY WAS TAKEN TO THE PANDA WARMER AND AS REQUIRED, INTERMITTENT POSITIVE AIR PRESSURE WAS STARTED. THE AIR CYLINDER EMPTIED VERY QUICKLY WITHIN APPROXIMATELY 3 MINUTES. THE EMPTY AIR CYLINDER WAS REPLACED WITH A NEW CYLINDER AND THE AIR EMPTIED AGAIN AFTER APPROXIMATELY 3 MINUTES. A THIRD AIR CYLINDER WAS EXCHANGED AND THIS, TOO, ALSO EMPTIED AFTER 3 MINUTES. THE BLENDER WAS SET FOR 100% OXYGEN, BUT THERE WAS NO GAS AND THE SUCTION DID NOT WORK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING RESUSCITATION OF A NEWBORN INFANT, THE NON-GE AIR CYLINDER UNEXPECTEDLY EMPTIED ITS CONTENTS PREMATURELY WHILE ATTACHED TO THE GIRAFFE PANDA IRES WARMER. THE INFANT WAS REPORTEDLY ADMITTED TO THE SPECIAL CARE NURSERY DUE TO HYPOXIA. IT WAS REPORTED TO GE HEALTHCARE THAT THE WARMER WAS CHECKED BY THE HOSPITAL'S BIOMEDICAL ENGINEERING STAFF AND NO MALFUNCTION WAS FOUND. THE INFANT REPORTEDLY HAS RECOVERED AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823670 PANDA IRES WARMER INFANT RADIANT WARMER FMT OHMEDA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other