BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1081039 · Received July 18, 2008

    Report

    Report Number
    3023750-2008-00173
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    February 29, 2008
    Report Date
    May 7, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR. THE USER RETURNED THE ACTUAL DEVICE FOR EVALUATION. THE USER REPORTED THAT THE SPO2, OR PULSE OXIMETRY, FUNCTION DID NOT WORK. THE USER INDICATED THAT THERE WAS NO PT CONNECTED TO THE DEVICE AT THE TIME OF THE OBSERVATION, WHICH WAS IN 2008, MORE THAN TWO MONTHS BEFORE THEY REPORTED IT TO WELCH ALLYN. WE RECEIVED THE UNIT FOUR MONTHS LATER, AND COULD NOT DUPLICATE ANY SPO2 MALFUNCTION, BUT WE FOUND THAT THE CUSTOMER HAD SENT BACK SPO2 PROBES THAT WERE INCOMPATIBLE WITH THEIR UNIT. WE INFORMED THE CUSTOMER OF THE INCOMPATIBILITY AND QUOTED THEM FOR THE CORRECT SPO2 PROBES, BUT THEY DECLINE. DURING FINAL TEST ON THIS UNIT FIFTHTEEN DAYS LATER, PRIOR TO SENDING THE UNIT BACK TO THE CUSTOMER, FACTORY SERVICE DISCOVERED THAT THE UNIT WOULD INTERMITTENTLY FAIL TO POWER UP ON AUXILIARY POWER. THIS IS A REPORTABLE MALFUNCTION, SO THAT IS THE DATE ENTERED IN BLOCK G4 OF THIS FORM. FACTORY SERVICE ISOLATED THE FAILURE TO THE AUXILIARY POWER CABLE CONNECTOR. THEY FOUND THAT PIN 6 ON THE CONNECTOR WAS NOT FULLY SEATED WITHIN THE CONNECTOR, CAUSING AN INTERMITTENT CONNECTION. THE CUSTOMER DID NOT REPORT ANY POWER PROBLEMS, POSSIBLY INDICATING THAT THE PIN BECAME UNSEATED DURING SERVICE. FACTORY SERVICE RE-INSERTED AND LOCATED THE PIN TO RESTORE NORMAL OPERATION. SUBSEQUENTLY, THE DEVICE PASSED ALL ACCEPTANCE TESTING AND WE RETURNED IT TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IN 2008, THAT ON THE EVENT DATE, THEY FOUND THAT THE SPO2 FUNCTION DID NOT WORK DURING CHECKOUT. SPO2 MALFUNCTIONS ARE NOT NORMALLY REPORTABLE. WE RECEIVED THE UNIT FOUR MONTHS LATER, AND COULD NOT DUPLICATE ANY SPO2 MALFUNCTION, BUT WE FOUND THAT THE CUSTOMER HAD SENT BACK SPO2 PROBES THAT WERE INCOMPATIBLE WITH THEIR UNIT. DURING FINAL TEST ON THIS UNIT, FIFTHTEEN DAYS LATER, FACTORY SERVICE DISCOVERED THAT THE UNIT WOULD INTERMITTENTLY FAIL TO POWER UP ON AUXILIARY POWER. THIS IS A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC MKJ WELCH ALLYN PROTOCOL, INC. PIC 50

    Patients

    Seq Age Sex Outcome Treatment
    1