BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8258476 · Received January 17, 2019

    Report

    Report Number
    2031642-2019-00388
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Report Date
    December 31, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT : 25JUN2019, DATE REC¿D BY MFR : 24JUN2019. THERE WAS NO ON-SITE EVALUATION BY THE MANUFACTURER; THE CUSTOMER REPORTED THAT THE VENTILATOR WAS REPAIRED IN-HOUSE. THE CUSTOMER REPORTED THAT THE REPLACEMENT OF THE CPU BOARD (CPU PRINTED CIRCUIT BOARD ASSEMBLY, PART NUMBER 1123932) WAS UTILIZED TO ADDRESS AND REPAIR THE REPORTED CONDITION. THE DEVICE ALSO REPORTED TO HAVE BEEN 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

    EVENT DATE: (B)(6) 2018. DATE OF REPORT: 17JAN2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WAS A BACKUP ALARM FAILURE, CODE 1104. NO PATIENT OR USER HARM WAS REPORTED. EVENT DATE NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52396 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1