BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART RATE MONITOR

    MDR report key: 850395 · Received May 9, 2007

    Report

    Report Number
    2244861-2007-00002
    Event Type
    Death
    Date Received
    May 9, 2007
    Report Date
    May 9, 2007
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    BZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MONITOR NOT RETURNED. REPEATED CALLS TO REPORTER DOES NOT PRODUCE NEW INFO. THERE IS LEGAL INVOLVEMENT TYING UP THE MONITORS RETURN AND THEY ARE RELUCTANT TO DISCUSS THE "CASE", EXCEPT TO SAY THAT THEY DO NOT BELIEVE THE MONITOR MALFUNCTIONED OR WAS IN ANY WAY IMPLICATED.

    Description of Event or Problem · 1

    HOME CARE DEALER REPORTS A 20 MINUTES GAP IN THE MONITORS TRACE PRINTOUT. IN A COMMENT SOMEWHAT OFF-HAND, IT WAS STATED THAT THE REASON FOR THE INQUIRY WAS BECAUSE A PT HAD DIED. THE PERSON REPORTING THIS SAID THE MONITOR WAS NOT IMPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART RATE MONITOR BREATHING FREQUENCY MONITOR BZQ CAS MEDICAL SYSTEMS, INC. 9700B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR