BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8249813 · Received January 15, 2019

    Report

    Report Number
    2031642-2019-00344
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Report Date
    December 27, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT DATE: 26JAN2019. DATE REC'D BY MFR: 24JAN2019. CUSTOMER REPORTED OPERATING HOURS = 27,256. PHILIPS TECHNICAL SUPPORT RECOMMENDED REPLACING USER INTERFACE TO 2ND GENERATION AND PROVIDED PART NUMBER 1100822. REC'D EMAIL CORRESPONDENCE: CUSTOMER WRITES, "REPLACEMENT OF THE USER INTERFACE DID TAKE CARE OF THE PROBLEM, AND THE UNIT RETURNED TO SERVICE". SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 15JAN2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DISPLAY WAS DIM. THERE WAS NO PATIENT OR USER HARM REPORTED. THE EVENT DATE WAS NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44204 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1