BEUDAMED
    FDA Adverse Event Other Summary report: N

    MASSIMO

    MDR report key: 5090766 · Received September 16, 2015

    Report

    Report Number
    MW5056293
    Event Type
    Other
    Date Received
    September 16, 2015
    Report Date
    September 16, 2015
    Manufacturer
    MASSIMO
    Product Code
    DQA
    Report Source
    Voluntary report
    Reporter Occupation
    0

    Narratives

    Description of Event or Problem · 1

    AT 0620, PT HAD A PULSE OX OF 81% ON THE MONITOR. THE ABG DONE AT THAT TIME HAD A SAT OF 95.4%. AT 0715, PT HAD A PULSE OX OF 63% ON THE MONITOR, THE ABG DONE AT THAT TIME HAD A SAT OF 78.4%. PT HAD AN EMERGENT BRONCH STARTED AT 0819 THAT RESULTED IN THE PT SATS ON THE MONITOR DROPPING TO 70%. THE PT WAS BAGGED BY RT AND MD WITH A BAG EQUIPPED WITH A PEEP VALVE. SATS CONTINUED TO DROP. THE RT, NOW 2 WERE IN THE ROOM AND THE 2 RNS CHANGED THE PULSE OX CABLE, AND ON THE LEFT HAND AND A PEDIATRIC SENSOR PLACED ON THE RIGHT HAND OBTAINED A POOR PLETH AND A SAT OF 70%. AN ABG DONE THEN HAD AN O2 SAT OF 100%. RT ALSO OBTAINED A INDEPENDENT PULSE OX BOX AND IT WOULD NOT PICK UP A SAT OR PLETH FROM ANY SITE ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614436 MASSIMO PULSE OX DQA MASSIMO

    Patients

    Seq Age Sex Outcome Treatment
    1