BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE D PLUG

    MDR report key: 14316706 · Received May 7, 2022

    Report

    Report Number
    2249723-2022-01075
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 11, 2022
    Report Date
    March 30, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567109008
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) SPOKE TO THE CUSTOMER VIA PHONE AND CAME TO THE CONCLUSION THAT THE ZEROING OF THE TRANSDUCER WAS NOT DONE PROPERLY BY THE OPERATOR OF THE UNIT. THE FSE INSTRUCTED THE OPERATOR ON HOW TO PROPERLY PERFORM THIS, AFTER THE GUIDANCE THE PRESSURE READING WAS FOUND TO BE CORRECT. UNIT WAS CONNECTED TO PATIENT AND IS WORKING IN SATISFACTORY CONDITION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, E1 (SITE COUNTRY), G3, G6, H2, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), H10. ADDITIONAL INFORMATION: E1 (EVENT SITE POSTAL CODE:122505). IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) THERE WAS ZEROING OF TRANSDUCER. GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED AND FOUND THERE WAS ZEROING OF TRANSDUCER WAS NOT DONE PROPERLY WHICH WAS GUIDED TO OPERATOR ,AFTER THAT WORK DONE PRESSURE READING WERE FOUND CORRECT. UNIT IS CONNECTED TO PATIENT AND IS WORKING IN SATISFACTORY CONDITION. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WOULD NOT ZERO. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516673 CARDIOSAVE HYBRID TYPE D PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-33 10607567109008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown