BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP70 INTELLIVUE PT MONITOR

    MDR report key: 2154585 · Received June 30, 2011

    Report

    Report Number
    9610816-2011-00371
    Event Type
    Death
    Date Received
    June 30, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 27, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DESCRIPTION NOTES THAT ON (B)(6), 2011 AT APPROXIMATELY 11:53 AM, AN INTENSIVE CARE PT'S HEART RATE DECREASED BELOW THE LOW HEART RATE ALARM LIMIT. ALTHOUGH THE BEDSIDE MONITOR DID PRODUCE A BRADYCARDIA ALARM, IT WAS FELT THAT THERE WAS A DELAY BY THE BEDSIDE MONITOR IN PRODUCING AN ALARM TO ALERT THE CLINICIAN. PT HARM/INJURY IS POSSIBLE AS SHOULD THE CLINICIAN NOT BE ALERTED TO A CHANGE IN PT STATUS WHICH IS OUTSIDE OF THE RECONFIGURED MONITOR PT PARAMETER SETTINGS. NO PRODUCT MALFUNCTION WAS IDENTIFIED. THE CENTRAL MONITOR'S DIAGNOSTIC LOGS (REFLECT THE BEDSIDE AND CENTRAL MONITOR'S ALARMS) AND ECG MONITORING STRIPS FROM THE EVENT TIME WERE REVIEWED UPON RECEIPT. THE ALARM INFORMATION FROM THE MONITOR'S DIAGNOSTICS LOGS FOR BED # ICU BED 7 AT THE TIME OF THE EVENT FOLLOWS: ON 11:53:51 (B)(6) 2011 ICU 7 RED ALARM SOUND - BED - THE CENTRAL MONITOR IS SOUNDING A RED ALARM SOUND FOR AN ALARM EVENT GENERATED BY A BEDSIDE-MONITORED PARAMETER. ON 11:53:51 (B)(6) 2011 ICU 7 ALARM BRADY 28 < 30 - A RED/CRITICAL ALARM HAS OCCURRED WHICH WENT BELOW THE CONFIGURED BRADYCARDIA LIMIT THRESHOLD OF 30 FOR THE CONFIGURED TIMEFRAME. ON 11:53:57 (B)(6) 2011 ICU 7 ALARM ASYSTOLE - NO QRS DETECTED FOR A PERIOD GREATER THAN THE ASYSTOLE THRESHOLD (IN THE ABSENCE OF VFIB OR CHAOTIC ECG). THE EARLIEST SUBMITTED ECG STRIP FROM ICU BED#7 AT THE EVENT TIME, INDICATES THAT A YELLOW ALARM WAS INITIATED AT 11:48:26 FOR A PAIR OF PVCS (CONDITION WHICH TRIGGERS THIS ALARM - A NON-VENTRICULAR CONTRACTION, FOLLOWED BY TWO VENTRICULAR CONTRACTIONS, FOLLOWED BY A NON-VENTRICULAR CONTRACTION HAS BEEN DETECTED). SUBSEQUENT YELLOW ALARMS FROM THE ECG MONITORING STRIPS INCLUDE: ON 11:52:39 (B)(6) 2011 ICU 7-HR 43<50- THE HEART RATE HAS FALLEN BELOW THE LOW ALARM LIMIT. ON 11:53:19 (B)(6) 2011 ICU 7-ALARM PAUSE- NO BEAT DETECTED FOR A PERIOD GREATER THAN THE PAUSE THRESHOLD. THIS ALSO INDICATES THAT THE HR ALARM WAS PAUSED BY THE USER AFTER IT SOUNDED. A PHILIPS TECHNICAL ENGINEERING INSPECTION OF THE CITED MONITOR AFTER THE TIME OF THE EVENT FOUND THAT THE BEDSIDE MONITOR WAS FUNCTIONING PER MANUFACTURE'S SPECIFICATIONS. HAZARD ANALYSIS- THE INFORMATION PROVIDED RELATED TO THIS SITUATION DOES NOT SUPPORT THAT THERE IS A SYSTEMIC PROBLEM, DESIGN/LABELING MALFUNCTION OR ANY HEALTH RISK. NO CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED FOR THE MANUFACTURE. CONSIDERATION OF THIS COMPLAINT AND SIMILAR COMPLAINTS SUPPORTS THAT THERE IS NO DESIGN, MANUFACTURING, MATERIALS, OR LABELING PROBLEM.

    Description of Event or Problem · 1

    THE REPORTED DESCRIPTION NOTES THAT ALTHOUGH THE MONITOR DID PRODUCE HIGH PRIORITY PT ALARMS, THE USER INDICATES THAT THE TIME THE ALARMS WERE TRIGGERED IS EQUAL TO THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP70 INTELLIVUE PT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1