BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESUSCITAIRE RADIANT WARMER

    MDR report key: 929344 · Received October 17, 2007

    Report

    Report Number
    2510954-2007-00002
    Event Type
    Other
    Date Received
    October 17, 2007
    Date of Event
    September 14, 2007
    Report Date
    October 15, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, (PNC)
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER RECEIPT OF THE REPORT, A TELEPHONE CONVERSATION WAS HELD IN 2007 WITH THE BIOMEDICAL ENGINEER AT THE HOSPITAL, WHO REPORTED THE EVENT. HE ADVISED THAT THE RETAINING SPRING (ITEM I OF THE QUARTZ HEATER ASSEMBLY REMOVAL AND REPLACEMENT INSTRUCTIONS) BECAME DISLODGED AND THE SECONDARY REFLECTOR (ITEM J OF THE QUARTZ HEATER ASSEMBLY REMOVAL AND REPLACEMENT INSTRUCTIONS) FELL ON THE PATIENT CAUSING TWO MINOR BURNS. THE BIOMED ENGINEER REPORTED THE EVENT HAPPENED WHEN THE NURSE MOVED THE WARMER HEAD AWAY TO TAKE X-RAYS, AND WHEN RETURNING THE HEAD TO NORMAL POSITION, THE PART FELL OUT. HE INDICATED THAT THE RETAINING SPRING WAS DISTORTED. HE AGREED TO SEND THE PART BACK FOR EVALUATION. THE SUBJECT DEVICE WAS DELIVERED IN 2002. WE INQUIRED IF THE HEATER ELEMENT WAS PREVIOUSLY REPLACED AND HE REPLIED THAT ELEMENT WAS REPLACED MORE THAN ONCE IN THE PAST. IT SHOULD BE NOTED THAT THEY DO NOT HAVE A SERVICE CONTRACT WITH DRAEGER MEDICAL. A MONTH AFTER THE FIRST TELEPHONE CONVERSATION IN 2007, A CALL WAS PLACED TO SEAN TO INQUIRE ABOUT THE RETURN STATUS OF THE DAMAGED SPRING. SEAN INDICATED THAT HE WOULD NOT BE RETURNING THE RETAINING SPRING FOR EVALUATION, AND THAT HE PERFORMED HIS OWN REPAIR OF THE DEVICE. AS A RESULT, WE ASKED IF WE COULD PERFORM A COURTESY INSPECTION OF THE DEVICE FOR WHICH HE AGREED. THE ONSITE COURTESY INSPECTION WAS CONDUCTED AND REVEALED THAT THE HEATER ELEMENT AND SECONDARY REFLECTOR WERE INSTALLED CORRECTLY, AND A FULL OPERATIONAL CHECKOUT WAS PERFORMED AND THE UNIT OPERATED ACCORDING TO SPECIFICATIONS. WE ALSO ASKED IF WE COULD INSPECT OR PHOTOGRAPH THE DISTORTED RETAINING SPRINGS. HE INDICATED, THE RETAINING SPRINGS WERE INTENTIONALLY DISCARDED. THE RETAINING SPRING IS DESIGNED TO SECURE THE HEATER ELEMENT AND SECONDARY REFLECTOR TO HEATER MOUNTING BRACKET. THIS SPRING DESIGN HAS BEEN IN USED SINCE THE INCEPTION OF THE PRODUCT IN 1994, AND WE HAVE RECEIVED NO SIMILAR REPORTS OF DISTORTED RETAINING SPRINGS OR SECONDARY REFLECTORS FALLING TO THE MATTRESS. WITHOUT THE SUBJECT PARTS, NO FURTHER INVESTIGATION CAN BE PERFORMED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE NURSE PIVOTED THE WARMER HEAD FOR X-RAYS AND RETURNED THE WARMER HEAD TO NORMAL POSITIONING, THE RETAINING SPRING THAT HOLDS THE SECONDARY REFLECTOR IN PLACE BECAME DISLODGED AND THE SECONDARY REFLECTOR FELL ON THE PATIENT CAUSING TWO MINOR BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUSCITAIRE RADIANT WARMER INFANT RADIANT WARMER FMT DRAEGER MEDICAL SYSTEMS, (PNC) RW82 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR