BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3155 INFO CTR DB REL F.0

    MDR report key: 6165732 · Received December 12, 2016

    Report

    Report Number
    1218950-2016-07791
    Event Type
    Death
    Date Received
    December 12, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 17, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K041741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INITIAL REVIEW OF THE LOGS INDICATE THAT ALARMS WERE OCCURRING FOR THE PATIENT BETWEEN 22:00-23:00 AND SEVERAL WERE SILENCED AT THE CENTRAL STATION. THIS INFORMATION WAS RELAYED TO THE BIOMEDICAL ENGINEER, AND CIU MANAGER, HOWEVER, THEY SPECIFICALLY WERE INTERESTED IN WHY AN ASYSTOLE DID NOT OCCUR BETWEEN 22:02-22:12 SINCE THERE WAS AN AGONAL RHYTHM. PER COMMUNICATIONS VIA (B)(4) WITH THE BIOMEDICAL ENGINEER, BIOMEDICAL MANAGER, CIU MANAGER, RISK SPECIALIST, QUALITY SPECIALIST, AND QUALITY SPECIALIST (RN), IT WAS DETERMINED THAT THERE WAS SOME CONFUSION OVER ALARM BEHAVIOR SURROUNDING ALARM REMINDERS. THE PHILIPS QUALITY SPECIALIST (RN) EXPLAINED THE ALARM BEHAVIOR REGARDING ALARM REMINDERS AND ALSO STATED THAT ALARMS CAN BE SILENCED AT CLIENTS, BUT NOT SHOW IN THE LOGS AT THE COCKPIT CENTRAL (WHICH IS WHAT THE PRESENT LOGS ARE FOR). THE CUSTOMER WAS ADVISED TO OBTAIN THE CLIENT LOGS TO CONFIRM, AND ALSO ADVISED THE BIOMEDICAL ENGINEER TO SIMULATE THE BEHAVIOR EXPLAINED WITH REGARD TO ALARM REMINDERS SO THEY CAN ACTUALLY UNDERSTAND THE BEHAVIOR. CLIENT LOGS WERE RECEIVED BY THE BIOMEDICAL ENGINEER WHICH DID SHOW THAT ASYSTOLE ALARMS WERE SILENCED AT THE CLIENT BETWEEN 22:02-22:12. IN ADDITION, THE BIOMEDICAL ENGINEER STATED THAT THEY HAD DONE SIMULATED TESTING AND FOUND THE BEHAVIOR AS EXPLAINED TO THEM. THIS IS CONSIDERED A USER MISUNDERSTANDING OF ALARM BEHAVIOR, AS WELL AS USER ALARM HANDLING.

    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

    THE CUSTOMER REPORTED A PATIENT DEATH THAT OCCURRED ON (B)(6) 2016 IN ROOM (B)(6), AND WANTED TO HAVE THE LOGS REVIEWED FOR INFORMATION ON ALARMS AND SILENCING SPECIFICALLY BETWEEN 22:00-23:00. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818155 M3155 INFO CTR DB REL F.0 NA MHX PHILIPS MEDICAL SYSTEMS M3155

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death