BEUDAMED
    FDA Adverse Event Death Summary report: N

    MODEL 9500 RESPIRATION/HEART RATE MONITOR

    MDR report key: 1944699 · Received December 17, 2010

    Report

    Report Number
    2244861-2010-00002
    Event Type
    Death
    Date Received
    December 17, 2010
    Date of Event
    September 29, 2009
    Report Date
    December 17, 2010
    Manufacturer
    AEQUITRON, OR NELLCOR/MALLINCKRODT
    Product Code
    FLS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CAS LEARNED OF THE DEATH BY WAY OF A NOTICE THAT A LAWSUIT HAS BEEN BROUGHT. THAT NOTICE ARRIVED 11/17/2010 NAMING THE DEFENDANTS AS RESPONSIBLE FOR THE BABY'S DEATH BECAUSE IT WAS CLAIMED THAT THE MONITOR DID ALARM, AWAKENING THE PARENTS, FOR SLOW HEART RATE WHEN IN FACT THE BABY HAD STOPPED BREATHING ALTOGETHER. CAS WAS NOT NAMED AS A DEFENDANT IN THE SUIT, BUT COUNSEL FOR THE PLAINTIFF DISCOVERED THAT CAS HAS MDR REPORTING RESPONSIBILITY FOR THE MONITOR DUE TO A PURCHASED AND SALE AGREEMENT FROM 2000. THE MONITOR WAS NEVER MANUFACTURED BY CAS, BUT WAS MANUFACTURED BY AEQUITRON AND OR (B)(4)/NELLCOR. WHEN CAS PURCHASED THE MONITOR BUSINESS FROM NELLCOR THIS MONITOR WAS ALREADY DISCONTINUED, HOWEVER, CAS HAD RESPONSIBILITY FOR THE REGULATORY AFFAIRS OF THIS AND OTHER MONITORS AS WELL AS SERVICING RESPONSIBILITY. THE COUNSEL FOR THE PLAINTIFFS HAS NOT RESPONDED TO A LETTER REQUEST FOR THE MONITOR SERIAL NUMBER, THEREFORE, IT CANNOT BE DETERMINED IF THIS PARTICULAR MONITOR EVER ENTERED THE FACILITY OF CAS. CAS CLEARLY DENIES ANY INVOLVEMENT IN THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 9500 RESPIRATION/HEART RATE MONITOR APNEA MONITOR FLS AEQUITRON, OR NELLCOR/MALLINCKRODT 9500

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Death