BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASCOM MOBILE MONITORING GATEWAY (MMG)

    MDR report key: 7800071 · Received August 20, 2018

    Report

    Report Number
    3008952681-2018-00001
    Event Type
    Death
    Date Received
    August 20, 2018
    Date of Event
    July 16, 2018
    Report Date
    August 19, 2018
    Manufacturer
    ASCOM SWEDEN AB
    Product Code
    MSX
    UDI-DI
    17350088670009
    PMA / PMN Number
    K111215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCLUSION BASED ON THE LOG ANALYSIS IS THAT THE MMG HAS OPERATED AS INTENDED (I.E. NO MALFUNCTION). ALARM NOTIFICATIONS HAVE BEEN DISTRIBUTED TO ONE HANDSET THAT WAS ASSIGNED. THE MMG HAS BEEN USED IMPROPERLY IN THE SENSE THAT THE ESCALATION LEVELS 2 AND 3 WERE NOT ASSIGNED BY THE USER FACILITY TO ANY OTHER HANDSET. WE REQUESTED FROM THE USER FACILITY A CONFIRMATION WHETHER THE MMG HAS CAUSED OR CONTRIBUTED TO THE EVENT, AND ALSO ADDITIONAL LOG INFORMATION PRIOR TO THE EVENT TO DETERMINE IF THERE WERE SIMILAR ISSUES PRIOR TO THIS EVENT. WE DECIDED TO REPORT THIS EVENT AS A POTENTIAL USE ERROR UNDER 21 CFR 803 BECAUSE WE CANNOT, BASED ON THE INFORMATION, RULE OUT THAT THE PRODUCT HAS CONTRIBUTED TO THE ADVERSE EVENT. WE HAVE NOT BEEN ABLE TO OBTAIN FROM A QUALIFIED PERSON A MEDICAL JUDGMENT THAT A DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    AS REPORTED TO ASCOM (US) INC., IN CUSTOMER COMPLAINT TICKET (B)(4): ON MONDAY (B)(6) 2018 AN ASYSTOLE ALARM WENT OUT TO THE HANDSET DEFINED AS LEVEL 1. THE NURSING STAFF SAID THAT THEY DID NOT GET THE ALARM FOR 4-5 MINUTES. (B)(6), BIOMED AT THE USER FACILITY ((B)(6) MEDICAL CENTER), MENTIONED THAT HE SAW THAT ONLY ONE LEVEL (LEVEL 1) WAS ASSIGNED IN THE SYSTEM WHEN HE CHECKED. HE ALSO SAID THAT THE PATIENT DIED BUT THAT NO EVENT OCCURRED, BECAUSE THE FEMALE PATIENT WAS SICK. THE USER FACILITY ASKED ASCOM TO INVESTIGATE THE LOG FILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639671 ASCOM MOBILE MONITORING GATEWAY (MMG) NETWORK AND COMMUNICATION MIDDLEWARE MSX ASCOM SWEDEN AB SW000400 NOT APPLICABLE 17350088670009

    Patients

    Seq Age Sex Outcome Treatment
    1 Death