BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4912449 · Received July 14, 2015

    Report

    Report Number
    2031642-2015-01301
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Report Date
    June 17, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION REGARDING THE DEVICE REPAIR AND PATIENT INFORMATION. TO DATE NO FURTHER DETAILS HAVE BEEN PROVIDED. THE SERVICE HISTORY RECORD WAS REVIEWED AND NO REPAIR INFORMATION WAS FOUND. THE CUSTOMER'S BIOMEDICAL ENGINEER EVALUATED THE DEVICE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS REQUESTED AND THE CUSTOMER HAS NOT RESPONDED. THE MANUFACTURER¿S OFFICE CONTACT PERSON ADDRESS IS (B)(4). THE CUSTOMER'S BIOMEDICAL ENGINEER EVALUATED THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED WITH DATA ACQUISITION PCBA ADC REFERENCE FAILED. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON PATIENT, BUT THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED WITH DATA ACQUISITION PCBA ADC REFERENCE FAILED. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON PATIENT, BUT THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456789 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1