BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BETA BIOMED SERVICES, INC.

    MDR report key: 1622995 · Received March 2, 2010

    Report

    Report Number
    1650347-2010-00001
    Event Type
    Malfunction
    Date Received
    March 2, 2010
    Date of Event
    February 18, 2010
    Report Date
    March 2, 2010
    Manufacturer
    BETA BIOMED SERVICES, INC.
    Product Code
    DQA
    PMA / PMN Number
    K011518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    I VISITED THE (B) (6) HOSPITAL ON (B) (6) 2010. UPON ARRIVAL, I MET WITH MR (B) (6), (B) (6) AND (B) (6). MR. (B) (6) LED ME TO THE ICU WARD TO VIEW THE PT'S FINGER. A BLISTER WAS LOCATED ON THE TOP RIGHT INDEX FINGER ABOVE THE 1ST INTERMEDIATE PHALANGE. THERE WAS ALSO A BRUISE ON THE DISTAL END OF THE FINGER. UPON ENTERING THE ICU ROOM, I DID NOTICE THAT THE REPLACEMENT PULSE OXIMETER SENSOR WAS TAPED TO THE PT'S FINGER. THIS IS WARNED AGAINST IN THE IFUS. AFTER VIEWING THE PT, I PROCEEDED TO THE CLINICAL ENGINEERING DEPARTMENT WITH MR. (B) (6). CE HAD SET UP A SIMILAR CONFIGURATION TO THE UNIT IN THE ICU WARD. A DIFFERENT PULSE OXIMETER SENSOR OF THE SAME LOT AND COMPATIBILITY WAS PLACED ON A SPO2 SIMULATOR. A TEMPERATURE PROBE WAS PLACED ON THE LED TO MONITOR THE TEMPERATURE. THE SENSOR PRODUCED A TEMPERATURE OF 83 DEGREES F. THE TEST WAS REPEATED WITH TWO SENSORS I BROUGHT WITH ME FOR THE VISIT. THE SAME RESULTS WERE PRODUCED. I WAS NOT ALLOWED TO TEST THE ALLEGED SENSOR. MR. (B) (6) AND I WERE NOT ABLE TO PRODUCE ANY FAULTS. WHEN I RETURNED TO MY LOCATION, MY ENGINEER (B) (4) INDICATED HE RECEIVED THE SAME RESULTS WITH HIS IN HOUSE TEST. I THEN PLACED THE SENSOR ON THE SIMULATOR ALONG WITH A TEMPERATURE PROBE BETWEEN THE LEAD AND THE LED. I TAPED THE SENSOR TO LEAD AND RAN IT FOR 4 HOURS. THE MAX TEMPERATURE THE THERMOMETER READ WAS 93 DEGREES F. NOTE: THE DESIGN OF THE BETA BIOMED SPO2 SENSOR PLACES THE LED DIRECTLY OVER THE FINGER NAIL, NOT OVER THE INTERMEDIATE PHALANGE. THE PAD DESIGN HAS A NATURAL FINGER STOP WHERE THE FINGER SHOULD BE PLACED. FIG 2 IN THE INSTRUCTIONS CLEARLY SHOW THE POSITIONING OF THE FINGER. THE IFU INDICATES TO MOVE THE SENSOR EVERY 4 HOURS. WE WERE NOT ABLE TO REPRODUCE ANY FAULT.

    Description of Event or Problem · 1

    (B) (6) HOSPITAL REPORTED THAT A BLISTER FORMED ON A PT'S FINGER WHERE A PULSE OXIMETER PROBE HAD BEEN PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BETA BIOMED SERVICES, INC. DQA BETA BIOMED SERVICES, INC. B505-1016 F9189RLW

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention