BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE REDUCTION VALVE

    MDR report key: 218303 · Received April 9, 1999

    Report

    Report Number
    1057212-1999-00002
    Event Type
    Malfunction
    Date Received
    April 9, 1999
    Date of Event
    March 18, 1999
    Report Date
    April 9, 1999
    Manufacturer
    LINDE AG
    Product Code
    MNJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PRESSURE REDUCTION VALVE (PRV) IS A COMPONENT TO ERBE USA'S ARGON PLASMA COAGULATOR. THE PRV IS NOT MANUFACTURED BY ERBE. THE MFR USED AN INCORRECT CONNECTOR ON THE PRV. CUSTOMER REPORTED THAT THE PRV WAS DIFFICULT TO THREAD INTO THE ARGON TANK. PRV WAS RETURNED TO ERBE USA. PRV WAS NEVER ORUSED AT THE ACCOUNT. NO PT WAS INVOLVED; NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE REDUCTION VALVE PRESSURE REDUCTION VALVE MNJ LINDE AG 20132-065 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other