BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANDA WARMER II

    MDR report key: 2858778 · Received November 20, 2012

    Report

    Report Number
    1121732-2012-00005
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    June 5, 2012
    Report Date
    June 5, 2012
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    PMA / PMN Number
    K122267
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S OXYGEN SATURATION RETURNED TO NORMAL LIMITS ONLY AFTER THE TEAM DISCOVERED THE MALFUNCTION. THE INFANT RECEIVED POTENTIALLY UNNECESSARY TREATMENT (I.E. CPAP) AND MAY HAVE RECEIVED OTHER UNNECESSARY TREATMENT (I.E. INTUBATION, MECHANICAL VENTILATION, SURFACTANT REPLACEMENT THERAPY) HAD THE MALFUNCTION NOT BEEN DISCOVERED. ON (B)(6) 2012, THE PANDA WARMER WAS REPAIRED. EIGHTEEN PANDA WARMERS WERE INSPECTED AND A SIMILAR PROBLEM WAS DISCOVERED WITH ONE ADDITIONAL WARMER, WHICH WAS ALSO REPAIRED AND PUT BACK IN SERVICE. MFR INDICATED NO FURTHER ACTION WAS NEEDED." GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. PT DATA HAS BEEN REQUESTED FROM HOSPITAL BUT HAS NOT BEEN RECEIVED TO DATE. THE USER FILED MEDWATCH REPORT INDICATED 'OTHER SERIOUS'; HOWEVER, BASED ON THE STATEMENT OBTAINED FROM THE BIOMEDICAL ENGINEERING MANAGER AT THE HOSPITAL THERE WAS NO PT INJURY.

    Description of Event or Problem · 1

    PER USER FILED MEDWATCH REPORT (B)(4): "DURING RESUSCITATION OF NEWBORN TWINS ((B)(6)) IT WAS NOTED THAT ONE OF THE TWO WAS NOT RESPONDING TO OXYGEN THERAPY AS WELL AS EXPECTED. A PEDIATRIC RESIDENT WAS PROVIDING BLOW-BY OXYGEN FOLLOWED BY CPAP IN AN EFFORT TO IMPROVE OXYGENATION, HOWEVER THE SPO2 CONTINUED IN THE LOW 80% RANGE WITH SIGNS OF RESPIRATORY DISTRESS, DESPITE INCREASES IN THE BLENDER'S SET FIO2. THE RESPIRATORY THERAPIST IN ATTENDANCE BEGAN TROUBLESHOOTING THE EQUIPMENT INVOLVED AND VERY QUICKLY NOTED THE KNOB FOR ADJUSTING FIO2 FELT LOOSE. HE TRANSITIONED THE PT TO A FLOWMETER ATTACHED TO WALL OXYGEN AND THE PT RESPONDED QUICKLY WITH INCREASED SPO2. IN FOLLOW-UP, AFTER THE PTS WERE STABILIZED, AN OXYGEN ANALYZER SHOWED THE BLENDER WAS DELIVERING 21% OXYGEN REGARDLESS OF SETTING. ANESTHESIA MAINTENANCE WAS CALLED TO REPAIR THE EQUIPMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other