BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPO2 SENSOR NEONATAL FOOT/HAND REUSABLE TRANSDUCER

    MDR report key: 2220153 · Received August 8, 2011

    Report

    Report Number
    9610816-2011-00475
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Report Date
    July 28, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT NOTES THAT AN M1193A SPO2 SENSOR, APPLIED FOR 2 HOURS, CAUSED A WATER BUBBLE ON PART OF THE HAND. NO REPORT WAS RECEIVED OF ANY EMERGENT TREATMENT OR PERMANENT DISABILITY WAS RECEIVED. PHILIPS IS REPORTING THIS ALLEGED HOT SENSOR LED ONLY UNTIL WE CAN RULE OUT THAT THERE WAS ANY POSSIBILITY OF HEALTH RISK. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE REPORTED COMPLAINT NOTES THAT AN M1193A SPO2, APPLIED FOR 2 HOURS, CAUSED A WATER BUBBLE ON PART OF THE HAND. NO REPORT WAS RECEIVED OF ANY EMERGENT TREATMENT OR PERMANENT DISABILITY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPO2 SENSOR NEONATAL FOOT/HAND REUSABLE TRANSDUCER DSI PHILIPS MEDICAL SYSTEMS M1193A

    Patients

    Seq Age Sex Outcome Treatment
    1