BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M3155 INFO CNTR NETWORK DB REL N.0

    MDR report key: 5360399 · Received January 12, 2016

    Report

    Report Number
    1218950-2015-07126
    Event Type
    Injury
    Date Received
    January 12, 2016
    Date of Event
    December 27, 2015
    Report Date
    December 28, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CARE SOLUTION CENTER REPRESENTATIVE VERIFIED THE ISSUE WITH THE CUSTOMER OVER THE PHONE. NO ON SITE SERVICE WAS REQUESTED AND NONE WAS PROVIDED. THE CARE SOLUTION CENTER REPRESENTATIVE INSTRUCTED THE CUSTOMER ON HOW TO OBTAIN THE CENTRAL STATION ALARM LOGS AND SEND THEM IN FOR REVIEW. A REVIEW OF THE CENTRAL STATION ALARM LOGS INDICATED THAT ON (B)(6) 2015 FOR 231902 FROM 20:12:18 UNTIL 20:41:53, THERE WAS 1 ***VTAH; 2 ***DESAT; 2 ***VFIB/TACH AND 2 ***ASYSTOLE ALARMS ANNUNCIATED. ONE OF THE ***DESAT ALARMS ANNUNCIATED FOR 10 MINUTES. A NURSE FROM THE CUSTOMER SITE CONTACTED PHILIPS TO REPORT THAT THE MX40 FAILED TO ALARM WHEN THE PATIENT'S HEART STOPPED. THE CARE SOLUTION CENTER REPRESENTATIVE INSTRUCTED THE CUSTOMER ON HOW TO OBTAIN THE CENTRAL STATION ALARM LOGS AND SEND THEM IN FOR REVIEW. A REVIEW OF THE CENTRAL STATION ALARM LOGS INDICATED THAT ON (B)(6) 2015 FOR 231902 FROM 20:12:18 UNTIL 20:41:53, THERE WAS 1 ***VTAH; 2 ***DESAT; 2 ***VFIB/TACH AND 2 ***ASYSTOLE ALARMS ANNUNCIATED. ONE OF THE ***DESAT ALARMS ANNUNCIATED FOR 10 MINUTES. THERE IS NO DATA TO SUPPORT A PHILIPS DEVICE MALFUNCTION. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    A NURSE FROM THE CUSTOMER SITE CONTACTED PHILIPS TO REPORT THAT THE MX40 FAILED TO ALARM WHEN THE PATIENT'S HEART STOPPED. IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE ICU. WE ARE CONSIDERING THIS AS A SERIOUS INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20974 M3155 INFO CNTR NETWORK DB REL N.0 CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 865418

    Patients

    Seq Age Sex Outcome Treatment
    1 Other