BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 11752895 · Received April 30, 2021

    Report

    Report Number
    2249723-2021-00915
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 9, 2021
    Report Date
    April 3, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: EMDR FOLLOWUP 3 CREATED IN ERROR . EMDR FOLLOWUP 2 CREATED IN ERROR . AS PER THE EMDR FOLLOWUP 1, AFTER FURTHER INVESTIGATION IT HAS BEEN CONFIRMED THAT THIS COMPLAINT IS NOT REPORTABLE AS THE REPORTED FAILURE OCCURRED ON AN IABP THAT IS USED FOR TRAINING PURPOSED ONLY. THIS RECORD IS TO RESCIND MFG REPORT # 2249723-2021-00915. KINDLY DISREGARD THE PREVIOUS EMDRS.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING TRAINING, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WOULD NOT DISPLAY THE SYSTEM TRAINER. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP AND HE WAS INFORMED THAT THE TRAINER WOULD NOT DISPLAY THE AUGMENTATION ON THE PRESSURE CHANNEL DURING TRAINING. FSE WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE BLUE POWER CABLE COULD BE MOVED TO MAKE THE ANOMALY COME AND GO. TO FIX THE ISSUE, THE FSE REPLACED THE TRAINER CABLE (0012-00-1830-01) FOR THE TRAINER. THE FSE COMPLETED A FULL SYSTEM TEST AS A PART OF THE SCHEDULED PM. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE TRAINER WAS RETURNED TO THE CUSTOMER FOR TRAINING (NON-CLINICAL) USE.

    Additional Manufacturer Narrative · 0

    EMDR FOLLOWUP 2 CREATED IN ERROR. AS PER THE EMDR FOLLOWUP 1, AFTER FURTHER INVESTIGATION IT HAS BEEN CONFIRMED THAT THIS COMPLAINT IS NOT REPORTABLE AS THE REPORTED FAILURE OCCURRED ON AN IABP THAT IS USED FOR TRAINING PURPOSED ONLY. THIS RECORD IS TO RESCIND MFG REPORT # 2249723-2021-00915. KINDLY DISREGARD THE PREVIOUS EMDR.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION IT HAS BEEN CONFIRMED THAT THIS COMPLAINT IS NOT REPORTABLE AS THE REPORTED FAILURE OCCURRED ON AN IABP THAT IS USED FOR TRAINING PURPOSED ONLY. THIS RECORD IS TO RESCIND MFG REPORT # 2249723-2021-00915.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP AND WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE BLUE POWER CABLE COULD BE MOVED TO MAKE THE ANOMALY COME AND GO. TO FIX THE ISSUE, THE FSE REPLACED THE TRAINER CABLE FOR THE TRAINER AND COMPLETED A FULL SYSTEM TEST (AS A PART OF THE SCHEDULED PM. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE TRAINER WAS RETURNED TO THE CUSTOMER FOR TRAINING (NON-CLINICAL) USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRAINING, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WOULD NOT DISPLAY THE SYSTEM TRAINER. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653931 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose