BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUUM REGULATOR

    MDR report key: 3002041 · Received February 12, 2013

    Report

    Report Number
    1924066-2013-00001
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    October 16, 2012
    Report Date
    February 12, 2013
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    KDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CALLED AND SENT E-MAIL TO REPORTING MEDICAL CENTER REQUESTING FURTHER INFORMATION. WE HAVE NOT YET RECEIVED ANY FURTHER INFORMATION. WE MANUFACTURE A NUMBER OF DIFFERENT VACUUM REGULATORS. WE DO NOT KNOW WHICH VACUUM REGULATORS THEY ARE REFERRING TO. WE ALSO DO NOT KNOW IF IT'S THE MODEL WHICH SHOULD BE USED FOR THIS APPLICATION. THEY DID NOT LIST A DATA CODE OR LOT NUMBER WE USE. THEREFORE WE DO NOT KNOW HOW HOLD THIS UNIT IS. WE HAVE BEEN MAKING VACUUM REGULATORS SINCE THE 1950'S. WE DO NOT KNOW WHAT KIND OF VACUUM SOURCE THEY WERE USING OR WHAT LEVEL OF VACUUM IT WAS PRODUCING. WE DO NOT KNOW HOW THIS PIECE OF EQUIPMENT WAS SET UP WITH THE VACUUM REGULATOR. AT 30 MMHG THE VACUUM IS JUST SLIGHTLY TURNED ON. THEREFORE ANY LEAKS IN THE SYSTEM BEING USED MAY CAUSE THE VACUUM LEVEL TO VARY. SINCE WE DO NOT KNOW ANY OF THE DETAILS INCLUDING WHICH VACUUM REGULATOR WAS INVOLVED WE ARE SUBMITTING THIS REPORT AS REQUIRED AND WILL INVESTIGATE FURTHER IF INFORMATION IS PROVIDED. WITHOUT A MODEL NUMBER OR PICTURES WE CANNOT DETERMINE IF THIS VACUUM REGULATOR IS OURS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ROBOTIC MVR WAS BEING PUMPED IN PREPARATION FOR A PROCEDURE. SURGEON REQUESTED VACUUM SET AT -40 MMHG. LATER IN THE CASE, THEY ATTEMPTED TO REDUCE VACUUM TO -30 MMHG. UNIT WAS UNABLE TO MAINTAIN CONSTANT PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62342 VACUUM REGULATOR VACUUM REGULATOR KDP ALLIED HEALTHCARE PRODUCTS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR