BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 1952702 · Received January 4, 2011

    Report

    Report Number
    1220063-2010-00097
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    November 25, 2010
    Report Date
    December 2, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S A105 PROCESSOR PCBA WAS EVALUATED AND FOUND TO HAVE A BURNT CAPACITOR IN THE BATTERY CHARGING CIRCUIT. THERE WERE BURN MARKS BUT NO PCB DAMAGE. A CONTINUITY CHECK WAS DONE TO VERIFY THAT THE REMAINING PARALLEL CAPACITORS IN THE CIRCUIT WERE NOT SHORTED. THE BURNT CAPACITOR AND TWO ADDITIONAL CAPACITORS WERE SENT TO THE SUPPLIER FOR FURTHER ANALYSIS, BUT THE SUPPLIER WAS UNABLE TO DETERMINE THE EXACT CAUSE FOR THE FAILED CAPACITOR. THERE WERE NO MFG PROBLEMS NOTED FROM THE MANUFACTURE DATE OF THESE CAPACITORS. THE ROOT CAUSE FOR THE FAILED CAPACITOR WITHIN THE PROCESSOR BOARD OF THE MONITOR IS UNK. DRAEGER PERFORMED A HEALTH HAZARD EVAL AND DETERMINED THAT THE STATISTICAL RISK FOR A SIMILAR OCCURRENCE IS CONSIDERED TO BE REMOTE. DRAEGER WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS OF THIS CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE NOTICED A SMELL COMING FROM A DELTA MONITOR AS IF SOMETHING HAD BURNT. IT STARTED TO ALARM AND THEN SHUT DOWN. THERE WAS NO PT INJURY REPORTED. DRAEGER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO