BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE HEMO

    MDR report key: 4954259 · Received July 21, 2015

    Report

    Report Number
    2183926-2015-00002
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    April 2, 2013
    Report Date
    July 20, 2015
    Manufacturer
    MERGE HEALTHCARE INCORPORATED
    Product Code
    DQK
    PMA / PMN Number
    K082421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER ((B)(6) HOSPITAL) WAS OFFERED A NEW UPS TO REPLACE THE DEFECTIVE UPS. A CALL WAS MADE TO (B)(4) ON 07/07/2015 TO DETERMINE IF ANY ADDITIONAL TESTING WAS PERFORMED ON THE RETURNED UPS AFTER MERGE HEALTHCARE RECEIVED THE ATTACHED DEVICE EVALUATION SUMMARY (TITLED FIELD FAILURE ANALYSIS REPORT DATED ON (B)(6) 2013) BECAME FIELD "6.0 - RECOMMENDATIONS" OF THE REPORT FROM THE TRIPP LITE STATED "AWAIT FURTHER ANALYSIS FORM FACTORY." A TECHNICAL SUPPORT PERSON AT (B)(4) REVIEWED THEIR RECORDS AND DETERMINED THAT NO ADDITIONAL RECORDS OF TESTING COULD BE FOUND. AS A RESULT, NO DEFINITIVE ROOT CAUSE WAS DETERMINED, BUT POTENTIAL ROOT CAUSES WERE SUGGESTED BY (B)(4) IN THE FIELD FAILURE ANALYSIS REPORT DATED (B)(6) 2013 AND ARE DOCUMENTED.

    Description of Event or Problem · 1

    THE MERGE HEMO SYSTEM IS USED TO MONITOR, MEASURE AND RECORD PHYSIOLOGIC DATA FROM A HUMAN PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. ONE OF THE HARDWARE COMPONENTS OF THE MERGE HEMO SYSTEM IS AN UNINTERRUPTIBLE POWER SUPPLY (UPS). A CALL WAS RECEIVED BY MERGE HEALTHCARE FROM A USER FACILITY STATING THAT A RECENTLY INSTALLED TRIPP LITE UPS WAS SMOKING, AND THE FIRE DEPARTMENT WAS CALLED. THE CONTROL ROOM CONTAINING THE UPS FILLED WITH SMOKE AND A BURNING ELECTRONICS SMELL. AS THE BIOMEDICAL ENGINEER UNPLUGGED THE UNIT FROM THE OUTLET, AN ARC OCCURRED. NO FLAMES WERE OBSERVED AND NO ONE WAS INJURED. UPON RETROSPECTIVE REVIEW, THIS ISSUE WAS DETERMINED TO BE REPORTABLE AS AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473335 MERGE HEMO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MERGE HEALTHCARE INCORPORATED 9.30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1