BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASCOM ALARM

    MDR report key: 17488305 · Received August 9, 2023

    Report

    Report Number
    MW5121003
    Event Type
    Death
    Date Received
    August 9, 2023
    Date of Event
    March 17, 2023
    Report Date
    April 13, 2023
    Manufacturer
    ASCOM US, INC.
    Product Code
    MSX
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORM YOU THAT GE HEALTHCARE (GEHC) RECEIVED A COMPLAINT FROM HOSPITAL (B)(6), FRANCE REPORTING THAT A PATIENT DEATH OCCURRED ON (B)(6) 2023. THE CUSTOMER ALLEGED THAT ALARMS WERE NOT PROVIDED AT THE ASCOM SECONDARY ALARM NOTIFICATION SYSTEM. THE CUSTOMER DID NOT MAKE ANY ALLEGATIONS AGAINST THE GEHC PATIENT MONITOR. GEHC INVESTIGATED THE EVENT BY COLLECTING AND REVIEWING THE LOG FILES FROM THE PATIENT MONITOR AND DETERMINED THAT THE MONITOR ALARMED APPROPRIATELY FOR THE EVENT. GEHC'S INVESTIGATION CONCLUDED THAT THERE WAS NO INDICATION OF A GEHC DEVICE MALFUNCTION AND THAT THE GEHC MONITOR DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688520 ASCOM ALARM SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS MSX ASCOM US, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown