BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALCO LABS, INC. PEDIATRIC ADJUSTABLE SENSOR

    MDR report key: 440169 · Received January 27, 2003

    Report

    Report Number
    2937177-2003-00001
    Event Type
    Other
    Date Received
    January 27, 2003
    Date of Event
    November 20, 2002
    Report Date
    January 9, 2003
    Manufacturer
    PALCO LABORATORIES, INC.
    Product Code
    DQA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 12/10/2002 ONE OF PALCO'S PRODUCT MANAGERS NOTIFIED THE QA MANAGER THAT A PULSE OXIMETER CUSTOMER REPORTED THE PALCO PULSE OXIMETER MODEL 400 USED WITH A PEDIATRIC ADJUSTABLE SENSOR ON A CHILD WAS CAUSING "BLISTER" THAT COULD BE 'BURNS' ON THEIR FINGERS AND TOES (SENSOR SITES). WHEN THE PRODUCT MANAGER RETURNED THE CALL THEY SPOKE TO THE ATTENDING RESPIRATORY THERAPIST WHO REPORTED THAT THE MARKS HAD BEEN APPEARING OVER A PERIOD OF 3 WEEKS DURING WHICH TIME THE AT-HOME PATIENT WAS BEING CONTINUOUSLY MONITORED FOR %SPO2. THE CUSTOMER REPORTED THAT THE CAREGIVER CHANGED THE SENSOR SITE EVERY 5 TO 8 HOURS. THE RESPIRATORY THERAPIST INDICATED THAT THE PATIENT IS ON A NUMBER OF MEDICATIONS AND SUSPECTS THE PATIENT'S SKIN IS VERY SENSITIVE. A SUBSEQUENT DISCUSSION WITH THE CUSTOMER AND PALCO'S QA MANAGER REVEALED THAT THE SKIN IRRITATION APPEARS ON THE TOP AND BOTTOM OF THE SENSOR SITE ONLY WHERE THE LENSES TOUCH THE SKIN. THE CAREGIVER ALTERS THE SENSOR BY CUTTING THE STRAP AND USES A VELCRO OR 'POSEY-WRAP' TO SECURE THE SENSOR AND LEAVES THE SENSOR ON THE SITE FOR UP TO 8 HOURS. PALCO SENSORS HAVE BEEN USED ON THE PATIENT FOR OVER A YEAR WITHOUT PREVIOUS PROBLEMS WITH SKIN IRRITATION. THE IRRITATION WAS NOT CONSIDERED SERIOUS BY THE CUSTOMER ONLY WORTH NOTING AND QUESTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALCO LABS, INC. PEDIATRIC ADJUSTABLE SENSOR PULSE OXIMETER SENSOR DQA PALCO LABORATORIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other PALCO LABS, INC. PULSE OXIMETER MODEL 400.