BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 11645632 · Received April 9, 2021

    Report

    Report Number
    2031642-2021-03337
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 11, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE V60 VENTILATOR DATA ACQUISITION PCB WAS RETURNED FOR FAILURE INVESTIGATIONS. THE DATA ACQUISITION PCBA WAS TESTED, AND NO FAILURES WERE IDENTIFIED. THE DEVICE WAS IN USE AT THE TIME OF THE REPORTED EVENT. THE DEVICE FUNCTIONED AS DESIGNED, AND TO MANUFACTURER DECLARED SPECIFICATIONS BY TERMINATING VENTILATION IN THE EVENT OF AN EXCESSIVE HIGH PRESSURE CONDITION IN ORDER TO PREVENT BAROTRAUMA TO THE PATIENT. THE ROOT CAUSE OF THE HIGH-PRESSURE CONDITION RESULTING IN THE 1009 CODE CANNOT BE DETERMINED. NO MALFUNCTION OF THE DEVICE HAS BEEN FOUND DURING INVESTIGATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WENT VENT INOPERABLE WHILE ON A PATIENT WITH PRESSURE REGULATION HIGH ERROR. THE CUSTOMER REPORTED THAT THE PATIENT'S OXYGEN SATURATION DECREASED TO 60S ON CONT. TELE MONITOR. THE RN WENT INTO THE ROOM AND FOUND THE BIPAP SCREEN TO BE READING "VENT INOPERATIVE PRESSURE REGULATION HIGH." THERE WAS NO AIR COMING OUT OF THE MASK. PT IMMEDIATELY PLACED ON NONREBREATHER, PT O2 SATURATION INCREASED. RESPIRATORY CALLED AND THE BIPAP MACHINE WAS REPLACED. PT. PLACED BACK ON CONT. BIPAP" THE CUSTOMER CONTACTED PRODUCT SUPPORT AND ADVISED THE CUSTOMER OF POSSIBLE DATA ACQUISITION (DA) OR MOTOR CONTROLLER (MC) PCB PER SUGGESTED REPAIR FOR PRESSURE REGULATION HIGH ERROR CODE. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON PATIENT , BUT THERE WAS NO PATIENT HARM REPORTED. THE PT WAS PLACED ON NONREBREATHER. THE UNIT WAS SWAPPED. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540691 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention