BEUDAMED
    FDA Adverse Event Death Summary report: N

    V60 VENTILATOR

    MDR report key: 2925824 · Received January 22, 2013

    Report

    Report Number
    2031642-2013-00032
    Event Type
    Death
    Date Received
    January 22, 2013
    Report Date
    December 26, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION; NO REQUEST BY CUSTOMER FOR CHECKOUT.

    Description of Event or Problem · 1

    RESPIRATORY THERAPY CLINICAL MANAGER (RTCM) REPORTED THE FOLLOWING: THE PATIENT BECAME DISCONNECTED FROM THE V60 AT THE MASK/CIRCUIT CONNECTION IN THE ICU AND NO ONE HEARD THE ALARM SOUNDING. THE VENTILATOR ALARM SETTING WAS SET AT LEVEL 2. THE PATIENT CODED AND DIED. THE PATIENT'S RESPIRATORY RATE ALARM ON THE PHILLIPS MONITOR HAD BEEN TURNED OFF AT SOME POINT AND THE NURSE NOT AWARE OF IT. THE PATIENT'S PULSE OXIMETER HAD COME OFF HIS FINGER. THE PATIENT HAD A PACEMAKER. THE PATIENT'S ROOM DOOR WAS OPEN AND ACROSS FROM THE NURSE'S STATION, BUT IT WAS A BUSY AREA FOR NOISE. THE NURSE ASSIGNMENT WAS SPREAD OUT, AND THERE WAS AN EMPTY ROOM BETWEEN THE PATIENT AND ANOTHER PATIENT WHO WAS NOT DOING WELL AND NEEDING THE NURSES ATTENTION. RESPIRATORY THERAPY WAS ON THE OTHER SIDE OF THE UNIT OUT OF EARSHOT. THE PATIENT WAS NOT ABLE TO USE A NURSE CALL AS HE WAS IN SOFT WRIST RESTRAINTS. EVALUATION OF THE OTHER VENTILATORS IN THE ICU DISCOVERED ALARM SETTINGS FROM 1-4. THEY ARE GOING TO INITIATE A PROTOCOL FOR A STANDARD ALARM SETTING. THE RTCM REPORTED THE PATIENT DEATH EVENT WAS NOT AN ISSUE IN WHICH THE VENTILATOR FAILED, AS IT WAS FUNCTIONING FINE. EVENT INVESTIGATION BY USER FACILITY CONCLUDED THE HOSPITAL STAFF DID NOT HEAR THE VENTILATOR WHEN IT ALARMED UPON CIRCUIT DISCONNECT. THE PATIENT CODED AND DIED AS A RESULT OF NON-RESPONSE BY STAFF TO THE ALARM. ALARM SETTING WAS FOUND SET AT A LOW VOLUME SETTING. THE FACILITY REPORTED THERE WAS NO VENTILATOR MALFUNCTION AND IT WAS OPERATING FINE. THE HOSPITAL WILL EVALUATE PROTOCOL FOR ALARM SETTINGS ON VENTILATORS. THIS EVENT IS REPORTED BASED ON USERS FAILURE TO RESPOND TO VENTILATOR ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29463 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PULSE OXIMETER| PHILIPS VITAL SIGNS MONITOR