BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHMEDA 1251 CONTINUOUS/INTERMITTENT VACUUM REGULATOR

    MDR report key: 9112784 · Received September 24, 2019

    Report

    Report Number
    3007409280-2019-00025
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    August 27, 2019
    Report Date
    August 27, 2019
    Manufacturer
    MEDICAL FITTINGS, INC.
    Product Code
    BYX
    PMA / PMN Number
    K904701
    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 THAT THE RELIEF HOLE WAS CLOGGED AND THE INTERMITTENT TIMING ASSEMBLY WAS BAD. THIS CONFIRMED THE REPORTED EVENT. THE TIMING ASSEMBLY WAS REPLACED AND ADJUSTED. THE RELIEF HOLE WAS CLEANED. THE DEVICE WAS TESTED ON A PUMP AND PASSED THE GAUGE, LEAK TEST - SUPPLY/PATIENT SIDE, REGULATION TEST, AND VISUAL INSPECTION. THE ROOT CAUSE FOR THE REPORTED REPEATED FAILURES WAS DETERMINED TO BE THE AGED PARTS THAT WERE REPLACED. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE DEVICES INTERMITTENT SUCTION WAS NOT WORKING AS IT WOULD NOT GO TO 0 (ZERO). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904387 OHMEDA 1251 CONTINUOUS/INTERMITTENT VACUUM REGULATOR MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN BYX MEDICAL FITTINGS, INC. M3355

    Patients

    Seq Age Sex Outcome Treatment
    1