BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 17229699 · Received June 29, 2023

    Report

    Report Number
    2249723-2023-03055
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 23, 2023
    Report Date
    October 7, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D1, D8, D9, G3, G6, H2, H3, H4, H6 INVESTIGATION TYPE, INVESTIGATION FINDINGS, COMPONENT CODES & INVESTIGATION CONCLUSIONS, H11. CORRECTED FIELDS: D4. A GETINGE FIELD SERVICE ENGINEER FSE WAS ABLE TO CONFIRM THE ISSUE. THE FSE REPLACED THE FRONT END BOARD. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER. THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT.FAT. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1164 REV. F, SERIAL NUMBER 18 00400 21_SPV WITH A REPORTED UNIT FAILURE OF THE ARTERIAL PRESSURE DROPPING TO ZERO AT TIMES. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE BOARD INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. TESTED THE PART FOR 2 HOURS WITH NO ISSUES FOUND. ARTERIAL PRESSURE DID NOT FAIL NOR WERE THERE ANY ALARMS PRESENT. FAT WAS NOT ABLE TO VERIFY THE REPORTED FAILURE.SENT THE BOARD TO THE SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT.FAT. THE FAT RECEIVED PART NUMBER 0670-00-1164 PCB, FRONT END, ROHS SERIAL NUMBER 18 00400 21_SPV FROM THE SUPPLIER. THE SUPPLIER PERFORMED HI-POT, IN CIRCUIT TESTING AND FUNCTIONAL TESTING, AND FOUND NO ISSUE WITH THE BOARD. THE BOARD PASSED TESTING. RETAINING THE BOARD IN THE FAT PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, WHILE ATTACHED TO A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) AND A SENSOR IAB, THE PHENOMENON THAT THE ARTERIAL PRESSURE BECAME ZERO OCCURRED FREQUENTLY. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422727 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male