BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT, MODEL 731

    MDR report key: 13144656 · Received January 3, 2022

    Report

    Report Number
    1220908-2021-04574
    Event Type
    Malfunction
    Date Received
    January 3, 2022
    Report Date
    December 13, 2021
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    CBK
    UDI-DI
    00847946024185
    PMA / PMN Number
    K111473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING FULL FUNCTIONAL TESTING, STRESS TESTING, AND POWER CYCLING WITHOUT DUPLICATING THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE LOG DOES SHOW INDICATION OF A SHUTDOWN DURING USE, SUCH AS A TIME GAP WITH ERROR 1172. THE 1172 SELF CHECK FAILURE OCCURS WHEN THE 5 VDC POWER BUS FAILS TO PROVIDE THE REQUIRED VOLTAGE. WHEN THIS ERROR OCCURS, THE DEVICE CAN RESULT IN A SHUT DOWN. IT IS UNKNOWN IF THE CUSTOMER PLACED THE VENTILATOR BEHIND THE 2000 GAUSS FIELD LINE, AS REQUIRED IN THE ZOLL OPERATORS GUIDE. THE PIM BOARD WAS REPLACED AS A PRECAUTION. THE DEVICE'S MANUAL FOR SAFETY INSTRUCTIONS ON HOW TO OPERATE THE DEVICE IN AN MRI ENVIRONMENT ADVISES: FAILURE TO FOLLOW ALL INSTRUCTIONS CAN RESULT IN MRI ARTIFACTS, INJURY TO THE PATIENT OR USER, OR MALFUNCTION OF THE DEVICE. YOU MUST FOLLOW ALL SAFETY PROCEDURES THAT ARE IN EFFECT FOR THE MRI ENVIRONMENT. DO NOT USE THE VENTILATOR IN AN MRI ENVIRONMENT WITH GREATER THAN 3T MAGNETIC FORCE. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS CONTACTED FOR RETURN OF THE SUSPECT PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO ZOLL FOR EVALUATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE, BEING USED WITHIN THREE FEET OF AN MRI MACHINE, INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2021-04521 AND 122098-2021-04575 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643486 UNI-VENT, MODEL 731 VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMBP-05-01 NA 00847946024185

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown