BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS MEDICAL SYSTEMS

    MDR report key: 566777 · Received January 6, 2005

    Report

    Report Number
    MW1034317
    Event Type
    Injury
    Date Received
    January 6, 2005
    Date of Event
    December 23, 2004
    Report Date
    January 6, 2005
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A V-FIB/TACH ALARM EVENT OCCURRED AT 09:53:55. THE PT WAS ON A WARD AND ASSIGNED TO A TELEMETRY BOX. THE PAGER DID NOT RECEIVE A PAGE. RPTR GOT A CALL AND TESTED THE PAGER BY SENDING THREE TEXT PAGES, NONE OF WHICH WERE RECEIVED. YOU SHOULD SEE THE PAGE ATTEMPTS AT 1103 HRS. RPTR REMOVED THE BATTERY, REINSTALLED THE SAME BATTERY, AND RE-SENT THE TEXT PAGE, AT WHICH POINT THE PAGER RECEIVED THE TEXT PAGE. THERE WAS NO HISTORY IN THE PAGER BECAUSE ALL THE PAGERS WERE CLEARED AT THE BEGINNING OF THE SHIFT, AND NO NEW PAGES SHOWED UP AS HAVING BEEN RECEIVED AFTER THE CLEARING.

    Description of Event or Problem · 1

    THE MODEL NUMBER OF THE DEVICE IS THE M3164A STATVIEW PAGING TRANSMITTER AND THE M3165A STAT VIEW PAGING RECEIVER. THE CUSTOMER WAS UNABLE TO PROVIDE A SERIAL NUMBER FOR THE TRANSMITTER. A VFIB/TACH ALARM EVENT WAS ANNUNCIATED AT THE PHILIPS INFO CTR BUT WAS NOT FOUND AT THE STATVIEW PAGING RECEIVER. THE HOSP BIOMED REP WENT TO THE CLINICAL UNIT AND ATTEMPTED TO SEND A TEXT PAGE THREE TIMES BUT THE PAGER DID NOT RECEIVE THE PAGE. THE REP THEN REMOVED AND REINSERTED THE BATTERY INTO THE RECEIVER AND NOTED THE PAGER THEN RECEIVED THE TEST PAGE. THE PAGER WAS REMOVED FROM SVC AND SENT TO PHILIPS FOR FURTHER ANALYSIS. THE CUSTOMER SUBMITTED THE PT ALARM STRIP; PAGER AND PAGING LOG FILES TO PHILIPS FOR FURTHER ANALYSIS. THE PAGER WAS ANALYZED TO ASSURE THE SERIAL NUMBER AND ADMINISTRATIVE CAPCODE WERE PROPERLY ENTERED INTO THE DEVICE. IF INCORRECTLY ENTERED, PAGES MAY NOT BE RECEIVED PROPERLY. THE PAGER WAS PROPERLY CONFIGURED. THERE WERE NO PAGING ALARM EVENTS FOUND IN THE MEMORY OF THE PAGER.; NO ANOMALIES WERE IDENTIFIED WITH THE PAGER. LOG FILES WERE ANALYZED AND IT WAS DETERMINED THAT THE PHILIPS INFO CTR DID ANNUNCIATE THE ALARM EVENT IN QUESTION, HOWEVER, THERE WAS NO CORRESPONDING ALARM ENTRY IN THE PAGING LOGS. THE ROOT CAUSE FOR THIS COULD NOT BE DEFINITIVELY DETERMINED, ALTHOUGH THE INFO CTR IS DESIGNED TO NOT PASS ALARMS THROUGH TO THE PAGING SYSTEM IN A FEW SITUATIONS, FOR EXAMPLE, IF A USER SILENCE AN ALARM AT A MONITOR WITHIN A FEW SECS. THE CUSTOMER INDICATED THAT THEIR USER MODEL IS CONSISTENT WITH PRODUCT LABELING, AND THEREFORE, THE FAILURE TO RECEIVE ALARM INFO ON THE PAGER DID NOT ADVERSELY AFFECT PT CARE. THE PRODUCT IS LABELED AS A SECONDARY MEANS OF ALARM NOTIFICATION. THE EVENT OCCURRED IN 2004. THE REPORT WAS RECEIVED IN THE ANDOVER OFFICE IN 3/23/05. THERE WERE NO DEATHS AND NO SERIOUS INJURIES THAT OCCURRED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS TELEMETRY PAGING SYSTEM DRG PHILIPS MEDICAL SYSTEMS STAT VIEW GE MEDICAL *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| O