BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA

    MDR report key: 1344941 · Received March 13, 2009

    Report

    Report Number
    1218950-2009-00264
    Event Type
    Death
    Date Received
    March 13, 2009
    Date of Event
    October 30, 2008
    Report Date
    October 31, 2008
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    DRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT ALLEGED THAT THE DEVICE DID NOT ALARM WHEN THE PATIENT'S PULSE RATE WENT BELOW DEFAULT VALUES. THE PATIENT SUBSEQUENTLY EXPIRED. THERE IS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH, NOR WAS THERE ANY INDICATION OF A DEVICE MALFUNCTION. THE HEART RATE LOWER LIMIT WAS SET TO ALARM IF THE PATIENT'S HEART RATE FELL BELOW 40 BEATS/MINUTE. HOWEVER, THE PATIENT'S INTERNAL PACEMAKER WAS SET TO DELIVER PACE PULSES IF THE PATIENT'S HEART RATE FELL BELOW 50 BEATS/MINUTE. REVIEW OF THE STRIPS BY THE HOSPITAL'S DIRECTOR OF NURSING INDICATED THAT THE PATIENT WAS BEING 100% PACED, BUT THE HEART MUSCLE WAS SLOWLY DYING. THE STRIPS ALSO INDICATED THAT THE BRADY (LOW HEART RATE) ALARM DID SOUND WHEN THE HEART RATE FELL BELOW 40 BEATS/MINUTES AND WAS SILENCED EACH TIME, ALONG WITH SIMILAR ASYSTOLE ALARMS, THAT WERE ALSO SILENCED. THIS EVENT WAS DETERMINED NOT TO BE A REPORTABLE DEATH OR SERIOUS INJURY BASED ON THE INFORMATION FROM THE DIRECTOR OF NURSING, AS WELL AS INDICATION THAT THE ALARMS DID SOUND WHEN THEY WERE SUPPOSED TO. THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED, AS THE ALARMS DID OCCUR WHEN INTENDED (<40 BEATS/MINUTE AND ASYSTOLE).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED NO ALARMS WHEN A PATIENT PULSE RATE BELOW THE DEFAULT VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA DRT PHILIPS HEALTHCARE 862205 (M3155)

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR