BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 19892409 · Received August 2, 2024

    Report

    Report Number
    3003521780-2024-00829
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Report Date
    July 4, 2024
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    PMA / PMN Number
    P160032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR REPORTED THAT THE CUSTOMER'S AED BATTERY PACK IS DEPLETED BEFORE THE EXPIRATION DATE. THE MAINTENANCE SCHEDULE IS NOT REPORTED. COMMUNICATION WITH THE DISTRIBUTOR: RECEIVED LOG HISTORY FILE ON 12 JUL FOR EVALUATION: THE DEVICE ENTERED SERVICE SEPTEMBER 2021. NO PADS WERE CONNECTED WHEN UNIT ENTERED SERVICE, NO PADS WARNING (NPW) DISPLAYED AND CONTINUED WITH THE ASI FLASHING RED AND CHIRPING. IN MARCH 2022 SERVICE CODE WARNING FOR DEPLETING BATTERY REPORTED 1X DURING WEEKLY CHECK AND CONTINUED WITH NPW. IN APRIL 2022, SERVICE CODE WARNING FOR TO HIGH CONDENSING HUMIDITY REPORTED 1X DURING QUARTERLY TEST; NPW CONTINUED ALONG WITH SERVICE CODE WARNING FOR DEPLETING BATTERY. ON APRIL 9, 2022 THE AED DISPLAYED SERVICE CODE WARNING FOR BATTERY VOLTAGE (MV) DUE TO CYCLE OF INCOMPLETE SELF-TESTS DUE TO DEPLETING BATTERY. IN JULY 2024 A NEW BATTERY PACK WAS INSTALLED, AND THE LOG HISTORY FILE WAS DOWNLOADED. ADVISED THE DISTRIBUTOR THAT THE AED SHOULD BE REMOVED FROM SERVICE AND TO KEEP THE PADS ATTACHED TO THE AED. CUSTOMER SERVICE TO HAVE CUSTOMER INSTALL NEW BATTERY PACK, CONNECT PADS, CLEAR THE SERVICE CODES WITH A MANUAL SELF-TEST AND CONFIRM THE ASI IS FLASHING GREEN; THE AED IS THEN OK TO REMAIN IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME TO FURTHER INVESTIGATE THIS EVENT. THE IFU STATES: ALTHOUGH THE DDU-100 SERIES AED IS DESIGNED FOR A WIDE VARIETY OF FIELD USE CONDITIONS, ROUGH HANDLING BEYOND SPECIFICATIONS MAY RESULT IN DAMAGE TO THE UNIT. IMPROPER MAINTENANCE CAN CAUSE THE DDU SERIES AEDS NOT TO FUNCTION AS DESIGNED. MAINTAIN THE DDU SERIES AED ONLY AS DESCRIBED IN THE USER MANUAL AND OPERATING GUIDE. THE AED CONTAINS NO USER-SERVICEABLE PARTS- DO NOT TAKE THE UNIT APART. FOLLOW ALL BATTERY PACK LABELING INSTRUCTIONS. DO NOT INSTALL BATTERY PACKS AFTER THE EXPIRATION DATE. FOLLOW ALL DEFIBRILLATION PAD LABEL INSTRUCTIONS. USE DEFIBRILLATION PADS PRIOR TO THEIR EXPIRATION DATE. THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE AVAILABLE INFORMATION DOES NOT REASONABLY SUGGEST THAT THE DEVICE DID NOT PERFORM AS INTENDED OR FAILED TO MEET PRODUCT SPECIFICATIONS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MDR SHALL BE SUBMITTED.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED THAT THE CUSTOMER'S AED BATTERY PACK IS DEPLETED. THE CUSTOMER DID NOT REPORT THAT THIS EVENT OCCURRED DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959142 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, L.L.C. DDU-100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown