BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISU, BSC, STD, CW DOM

    MDR report key: 4181743 · Received October 9, 2014

    Report

    Report Number
    1419185-2014-00014
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    May 12, 2014
    Report Date
    October 9, 2014
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    KDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A VACUUM REGULATOR. THE DEVICE ACHIEVES ITS FUNCTION VIA A REGULATOR MODULE THAT IS EQUIPPED WITH A DIAPHRAGM. THE USER FILED A COMPLAINT THAT THE REGULATOR GAUGE WAS JUMPY. DURING THE INVESTIGATION OF THE RETURNED DEVICES IT WAS DISCOVERED THAT THE MALFUNCTIONING UNITS HAD THEIR DIAPHRAGMS TORN. THE USER DID NOT REPORT ANY PATIENT INVOLVEMENT NOR ANY ADVERSE EVENT. THE USER ALSO DID NOT FILE A FORM FDA-3500A. THE MANUFACTURER IS FILING FORM FDA-3500A BECAUSE THIS WAS A MALFUNCTION THAT IF IT WERE TO RECUR, IT WOULD HAVE THE POTENTIAL TO CAUSE SOME PATIENT HARM. INVESTIGATION INTO THE ROOT CAUSE IN ONGOING AS OF THE DATE OF THIS REPORT AND IT HAS NOT YET BEEN DETERMINED THE EXTENT TO WHICH REMEDIAL ACTION WOULD BE APPROPRIATE TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO PUBLIC HEALTH. THIS MALFUNCTION WAS PREVIOUSLY REPORTED ON (B)(6) 2014 (MFR REPORT # 1419185-2014-00003), HOWEVER, MULTIPLE DEVICES WERE INCLUDED ON THAT REPORT IN ERROR.

    Description of Event or Problem · 1

    THE DEVICE IS A VACUUM REGULATOR INTENDED TO REGULATE SUCTION TO REMOVE BODY FLUIDS. ON (B)(6) 2014 IT WAS NOTED THAT 14 DEVICES WHICH HAD BEEN RETURNED FOR REPAIR CONTAINED DIAPHRAGMS WHICH HAD SIGNIFICANT TEARS IN THEM AFTER DEVICE LIFE OF LESS THAN 6 MONTHS. AT THE TIME ON QUALITY ASSURANCE AWARENESS ON (B)(6) 2014, PREVIOUS RETURNS WERE REVIEWED FURTHER TO DETERMINE IF ANY OTHER NEWER DEVICES HAD BEEN RETURNED WITH CONFIRMED DAMAGED DIAPHRAGMS. ONE ADDITIONAL DEVICE WAS NOTED. IT HAS BEEN DETERMINED THAT A TEAR IN THE REGULATOR DIAPHRAGM WHILE IN USE (AFTER VACUUM HAS BEEN SET) COULD RESULT IN AN INCREASE IN VACUUM TO THE PATIENT THAN WHAT HAD BEEN ORIGINALLY SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635447 ISU, BSC, STD, CW DOM VACUUM REGULATOR KDP OHIO MEDICAL CORPORATION 8700-0000-801 ISU137461

    Patients

    Seq Age Sex Outcome Treatment
    1