BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT INTESNIVE CARE SYSTEM

    MDR report key: 1712798 · Received June 4, 2010

    Report

    Report Number
    2510954-2010-00005
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    March 1, 2010
    Report Date
    June 3, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    FMT
    PMA / PMN Number
    KB75270
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER COMPLETED AN INVESTIGATION AND CONFIRMED THIS REPORT. THE HEAT STRESS DAMGE WAS CAUSED BY HIGH CONTACT RESISTANCE AT PIN 1 OF THE J5 CONNECTOR ON THE PRINTED CIRCUIT BOARD. THE THERMAL STRESS OCCURRED WITH THE AGING OF THE CONNECTOR. THIS FAILURE MODE RESULTED IN A MEDICAL DEVICE BULLETIN. THE DEVICE MATERIAL MEET THE APPLICABLE REQUIREMENTS OF UL 94V CLASSIFICATIONS AND ARE SELF EXTINGUISHING. THE POWER MODULE IN WHICH THE FAILURE OCCURRED IS SELF CONTAINED WITHIN THE WARMER MODULE. THE (B)(4) IS AN OPEN AIR DEVICE. DRAEGER WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS OF THIS CONDITION.

    Description of Event or Problem · 1

    A USER FACILITY REPORT WAS REC'D BY DRAEGER ON (B)(6) 2010 INDICATING A UNIT HAD AN INFANT IN A BASSINET, THE UNIT STARTED SMOKING IN THE AREA OF THE WARMER POWER MODULE. THE UNIT WAS REMOVED FROM SERVICE. NO PT INJURY WAS REPORTED. REFERENCE MFG COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT INTESNIVE CARE SYSTEM INFANT WARMER FMT DRAEGER MEDICAL SYSTEMS, INC. (PNC) IICS90 7830 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK