BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADA SYSTEM

    MDR report key: 13350022 · Received January 25, 2022

    Report

    Report Number
    3017425145-2021-00048
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    December 21, 2021
    Report Date
    January 25, 2022
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER IS NOT CURRENTLY AVAILABLE FOR THIS EVENT. REQUEST SENT TO SITE FOR LOT NUMBER, NO RESPONSE TO THIS REQUEST TO DATE. A GOOD FAITH EFFORT TO OBTAIN LOT NUMBER HAS BEEN ATTEMPTED. THE HEALTH CARE PROVIDER IN THIS EVENT REPORTS A HUMAN ERROR IN SETTING THE DEVICE UP TO SUCTION THAT CAUSED THE JADA DEVICE TO MALFUNCTION. AS THE TYPE OF MALFUNCTION WAS NOT IDENTIFIED, WE CANNOT RULE OUT THAT ITS RECURRENCE IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. THEREFORE, THIS EVENT WILL BE REPORTED AS A MALFUNCTION MDR.

    Description of Event or Problem · 0

    ON DECEMBER 28, 2021, ALYDIA HEALTH RECEIVED A COMPLETED JADA EXPERIENCE SURVEY (JES) FORM THAT REPORTED JADA STOPPED THE POSTPARTUM HEMORRHAGE (PPH) IN "GREATER THAN 10 MINUTES" AND NOTED, "JADA DID NOT WORK WELL INITIALLY DUE TO HUMAN ERROR BY ANCILLARY STAFF IN SETTING UP SUCTION CORRECTLY. AFTER CORRECTION MADE, DEVICE NO LONGER REALLY..." IN THE AREA ON THE SURVEY DESIGNATED FOR FEEDBACK WHEN JADA DID NOT STOP BLEEDING'. NOTE: THE ABOVE NOTED QUOTE IS INCOMPLETE IN THE SURVEY FORM, SO COPIED AS SUCH HERE. THE SITE HAS BEEN REQUESTED TO COMPLETE THIS SENTENCE IN THE RECORD BUT HAS NOT YET REPLIED AS OF THE DATE OF THIS SUMMARY. THE EVENT DATE FOR THIS SURVEY IS (B)(6) 2021. THIS PATIENT IS DESCRIBED IN THE SURVEY AS HAVING PPH STARTING 1-6 HOURS AFTER AN EMERGENCY CESAREAN SECTION (C-SECTION) DELIVERY. SHE HAS A MEDICAL HISTORY OF PRE-ECLAMPSIA WITH THIS PREGNANCY. PRIOR TO JADA USE, SHE RECEIVED 1 UNIT OF HEMABATE, 1 UNIT OF CYTOTEC, AND 2 UNITS OF TXA. THE PATIENT'S BLOOD LOSS PRIOR TO JADA USE WAS REPORTED AS 3500 ML, WHICH IS SEVERE PPH. THE AMOUNT OF BLOOD NOTED AS EVACUATED WITH JADA WAS LESS THAN 100 ML. A REQUEST WAS MADE FOR FOLLOW UP INFORMATION AND CLARIFICATION OF THE JES FORM. ON JANUARY 9, 2022, ALYDIA HEALTH EMPLOYEE RECEIVED AN EMAIL RESPONSE TO CLARIFICATION REQUESTED FROM THE HEALTH CARE PROVIDER THAT STATED THERE WAS A "MALFUNCTION DUE TO HUMAN ERROR WITH SUCTION SETUP." THERE WAS NO ADDITIONAL INFORMATION OR CLARIFICATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702553 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female