BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIIC IX UPGRADE FROM PIIC

    MDR report key: 6188515 · Received December 20, 2016

    Report

    Report Number
    1218950-2016-07909
    Event Type
    Death
    Date Received
    December 20, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 2, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION OCCURRED. THE LOGS DEMONSTRATE THAT THE PATIENT WAS ADMITTED ON (B)(6) 2016 AT 09:08 AND AT 10:12 THE ALARM SOURCE ON THE BEDSIDE MONITOR (MON 7) WAS CHANGED TO PULSE. THE PATIENT WAS ALSO CONNECTED TO AN MX40 WHICH WAS THE SOURCE FOR THE ECG ARRHYTHMIA ALARMS FOR THE PATIENT. THEN AT 16:16 ON (B)(6) 2016 THE MX40 WAS REMOVED FROM THE PATIENT, AT WHICH POINT THE BEDSIDE MONITOR WAS IN CONTROL. THE ONLY ALARMS THAT OCCURRED FOR THE PATIENT AFTER THE MX40 WAS REMOVED WERE RESPIRATION AND QTC. THE BEDSIDE MONITOR ALARM SOURCE HAD NOT BEEN CHANGED BACK TO HR FROM PULSE, SO PULSE REMAINED THE ALARM SOURCE. AT TWO TIMES IN THE LOGS, THE BEDSIDE MONITOR WAS RESUMED FROM STANDBY AND THE LOGS MADE A NOTATION THAT THE ECG/ARRHYTHMIA ALARMS WERE OFF. THIS IS CONSIDERED A USER ALARM HANDLING ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) AROUND 23:47 THERE WERE LONG PAUSES AND ASYSTOLE ALARMS THAT DID NOT AUDIBLY SOUND. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838853 PIIC IX UPGRADE FROM PIIC CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866117 RP5800

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death