BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9500 HEART RATE/RESPIRATION MONITOR

    MDR report key: 270028 · Received March 17, 2000

    Report

    Report Number
    2183157-2000-00064
    Event Type
    Malfunction
    Date Received
    March 17, 2000
    Date of Event
    February 22, 2000
    Report Date
    March 16, 2000
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A CALL FROM A REPRESENTATIVE OF FACILITY ON 02/22/2000. FACILITY CALLED TO REPORT THE FOLLOWING PROBLEM: NO APNEA ALARM ON INITIAL TEST. RESPIRATION "LED" JUST CONTINUES BEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9500 HEART RATE/RESPIRATION MONITOR BREATHING FREQUENCY MONITOR FLS NELLCOR PURITAN BENNETT 9500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other