BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHMEDA 1251 CONTINUOUS/INTERMITTENT VACUUM REGULATOR

    MDR report key: 9216422 · Received October 21, 2019

    Report

    Report Number
    3007409280-2019-00044
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 25, 2019
    Manufacturer
    OHIO MEDICAL PRODUCTS
    Product Code
    KDP
    PMA / PMN Number
    K801169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. INCOMING VISUAL INSPECTION DID NOT IDENTIFY ANY ANOMALIES. TECHNICAL VISUAL INSPECTION DID NOT IDENTIFY ANY ANOMALIES. DEVICE EVALUATION FOUND THE TIMING WAS OFF. THE TIMING WAS ADJUSTED. THE DEVICE WAS CALIBRATED. LEAK TEST AND SUCTION ACCURACY WAS TESTED AND PASSED. THE GAUGE TEST, LEAK TEST - SUPPLY/PATIENT SIDE, REGULATION TEST IN BOTH MODES ALL PASSED. THE FINAL VISUAL INSPECTION WAS GOOD. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, THE REPORTED ISSUE WAS MOST LIKELY DUE TO THE PRESSURE SENSOR FALLING OUT OF CALIBRATION. THIS WAS NOT RELATED TO THE PREVIOUS REPAIR. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE DEVICE GAUGE GOES ALL THE WAY AROUND WHEN THE SUCTION IS TURNED TO FULL AND ITS PORT IS OPEN. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010911 OHMEDA 1251 CONTINUOUS/INTERMITTENT VACUUM REGULATOR FREE FLOW VACUUM REGULATOR KDP OHIO MEDICAL PRODUCTS FROM1600

    Patients

    Seq Age Sex Outcome Treatment
    1