BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 340

    MDR report key: 408056 · Received July 29, 2002

    Report

    Report Number
    2937177-2002-00001
    Event Type
    Injury
    Date Received
    July 29, 2002
    Date of Event
    June 6, 2002
    Report Date
    July 25, 2002
    Manufacturer
    PALCO LABS, INC
    Product Code
    DQA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ON 07/2002 ONE OF PALCO'S INTERNATIONAL MARKETING REPS NOTIFIED PALCO'S QA MGR THAT A PULSE OXIMETER HOME USER IN A FOREIGN COUNTRY REPORTED THE PALCO PULSE OXIMETER MODEL 340 WITH A PALCO SENSOR USED ON A PT DID NOT ALARM WHEN PT STOPPED BREATHING. QA MGR CONTACTED THE USER AND WAS TOLD THE PT HAS PREEXISTING CONDITION OF SERIOUS BRAIN AND RESPIRATORY AND HAS HAD A TRACHEOTOMY. IN ADDITION, THE PT CANNOT MOVE. THE USER SAID SHE WAS USING PULSE OXIMETER TO MONITOR PT'S BREATHING CONDITION. WHILE THE PT WAS SITTING OUTSIDE IN THE SUN, PT'S HEAD FELL FORWARD CAUSING A BLOCKAGE TO PT'S AIRWAY. THE CUSTOMER SAID THE DEVICE DID NTO SOUND AN ALARM WHEN THE PT STOPPED BREATHING. WHEN THE USER NOTICED PT'S CONDITION, SHE HAD TO TAKE THE PT TO THE HOSPITAL WHERE PT WAS ADMITTED FOR ONE WEEK. SHE REPORTED PT MIGHT HAVE SUFFERED ADD'L BRAIN DAMAGE RESULTING FROM THE INCIDENT. THE USER WANTED TO KNOW WHY THE DEVICE DID NOT SOUND AN ALARM. IN ADDITION, SHE ASKED WHY THE DEVICE DOES NOT ALARM WHEN ITS BATTERY IS LOW. THE USER REPORTED THE DEVICE SHOWED AN ERROR CODE OF 135 WHEN IT IS IN THE SUN. THE QA MGR INFORMED HER THAT FROM THE DEVICE SPECIFICATIONS AND THE DEVICE MANUAL, THIS CODE TRANSLATES TO 'AMBIENT LIGHT TOO BRIGHT, DIRECT LIGHT ONTO SENSOR'. REGARDING THE LOW BATTERY INDICATOR, THE DEVICE WAS NOT DESIGNED TO ALARM WHEN THE BATTERY IS LOW. THE DEVICE DOES HAVE A LOW-BATTERY INDICATOR LIGHT. DURING THE INTERVIEW, THE USER SAID SHE DID NOT GET THE PULSE OXIMETER FROM A PHYSICIAN BUT INSTEAD RENTS THE UNIT DIRECTLY FROM A DISTRIBUTOR. SHE ALSO SAID SHE WAS OPERATING THE DEVICE WITHOUT A MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 340 PULSE OXIMETER DQA PALCO LABS, INC 340 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization| L| R