BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVER

    MDR report key: 19140200 · Received April 18, 2024

    Report

    Report Number
    3003521780-2024-00332
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Report Date
    March 20, 2024
    Manufacturer
    DEFIBTECH LLC
    Product Code
    MKJ
    PMA / PMN Number
    K081259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMUNICATION WITH THE CUSTOMER DID NOT IDENTIFY THE CAUSE FOR THE DEPLETED BATTERY PACK; HOWEVER, THE SERVICE CODE INDICATES THE "CAUSE MAY BE EXPOSURE TO COLD TEMPERATURES." THE LAST KNOWN MAINTENANCE DATE WAS IN 2022. THE CUSTOMER WAS ADVISED TO REMOVE THE BATTERY PACKS FROM THE DEVICES AND PROPERLY DISPOSE THEM. AS THE BATTERY PACK WILL NOT BE RETURNED FOR ANALYSIS, THE CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE IFU STATES: "IMPROPER MAINTENANCE CAN CAUSE THE DDU-2000 SERIES AED NOT TO FUNCTION. MAINTAIN THE DDU-2000 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.". THE AVAILABLE INFORMATION DOES NOT INDICATE THAT THE DEVICE DID NOT PERFORM AS INTENDED OR MEET PRODUCT SPECIFICATIONS.THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP MDR SHALL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RECEIVING A SERVICE CODE AND THE AED WILL NOT POWER ON. THE REPORTER STATED THE AED HAD BEEN STORED IN A TRAILER OUTSIDE THE FACILITY. THIS EVENT DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583332 REVIVER AUTOMATED EXTERNAL DEFIBRILATOR MKJ DEFIBTECH LLC DDU-2300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown