BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8971411 · Received September 6, 2019

    Report

    Report Number
    2031642-2019-08271
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Report Date
    September 19, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 06SEP2019. THE MANUFACTURER¿S INTERNATIONAL CUSTOMER SPECIALIST CONFIRMED THE REPORTED ISSUE. THE MANUFACTURER¿S INTERNATIONAL CUSTOMER SPECIALIST REPLACED THE DATA ACQUISITION (DA) BOARD. THE CUSTOMER RETURNED DATA ACQUISITION (DA) BOARD WAS TESTED AND NO FAILURES WERE IDENTIFIED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THIS MDR HAS BEEN REASSESSED AS REPORTABLE AFTER A REQUEST FROM THE FDA ON MARCH 1, 2019 TO REVIEW COMPLAINTS FROM 29 NOV 2017 TO 29 NOV 2018. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PRESSURE ACCURACY TEST FAILED AT THE 1HP SETTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765012 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1