BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CARE IICS90

    MDR report key: 1567889 · Received December 22, 2009

    Report

    Report Number
    2510954-2009-00006
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    May 27, 2008
    Report Date
    December 22, 2009
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    FMT
    PMA / PMN Number
    K875270
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH WE REQUESTED THE PARTS TO BE RETURNED THERE WERE NO PARTS RETURNED FOR EVALUATION. THE USER FACILITY ELECTED TO REMOVE THE UNIT FROM SERVICE DUE TO AGE OF THE UNIT AND COST OF REPAIR. HOWEVER, THE BIOMED AT THE FACILITY DID SEND PHOTOGRAPHS OF THE SUBJECT UNIT IN THE AREA OF THE POWER MODULE. BASED ON THE REVIEW OF THESE PHOTOGRAPHS THIS FAILURE APPEARS TO BE RELATED TO THE FAILURE MODE IDENTIFIED IN THE VOLUNTARY SAFETY ALERT INITIATED 1995 AND REISSUED IN SEPTEMBER OF 2000. BASED ON THE PHOTOGRAPHS SUPPLIED IT IS NOT CLEAR WHETHER THE CORRECTIONS DETAILED IN THE AFOREMENTIONED SAFETY ALERT WERE IMPLEMENTED. AS A RESULT, WE RESENT THE NOTIFICATION TO THE BIOMED WHO IN TURN INSPECTED THE REMAINING UNITS AT HIS FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER THAT THE POWER MODULE HAD CAUGHT FIRE. THERE WAS AN INFANT IN THE BASSINET AT THE TIME AND WAS MOVED IMMEDIATELY. THE INFANT DID NOT SUSTAIN ANY INJURY. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA