BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100,ENGLISH,NON-UTS,DOM

    MDR report key: 16726256 · Received April 12, 2023

    Report

    Report Number
    2249723-2023-01909
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    April 3, 2023
    Report Date
    March 27, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107394
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING USE THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A ISSUE OF MAINTENANCE CODE 1 ALARM. NO PATIENT INVOLVEMENT REPORTED. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS ABLE TO CONFIRM THE PROBLEM STATED BY CUSTOMER, UNIT WAS ALARMING MAINTENANCE CODE 1. PER SERVICE MANUAL HE REPLACED THE SOLENOID DRIVER BOARD (D012-00-1096-01) AND THE DRIVE MANIFOLD ASSEMBLY(D104-00-0018). UPON TESTING HE FOUND THE UNIT TO HAVE A VACUUM LEAK. HE TROUBLESHOT THE PUMP FOR LEAK BUT COULD NOT LOCATE THE LEAK. HE REMOVED MANIFOLD ASSEMBLY AND ADDED VACUUM GREASE TO THE ATM TRANSDUCER, WHILE INSTALLING THIS TRANSDUCER BACK ON HE ACCIDENTALLY BROKE OFF THE SCREW IN THE MANIFOLD BLOCK AND WAS NOT ABLE TO REMOVE IT. HE RETURNED WITH O-RING AND NEW DRIVE MANIFOLD AND REPLACING THE ASSEMBLY AND REPLACED PART. UPON TESTING HE FOUND THE PUMP TO NOT PULL A VACUUM OR PRESSURE, BUT COMPRESSOR WAS ON. WHILE TROUBLESHOOTING THE PUMP WOULD TURN OFF SPORADICALLY. HE CHECKED FOR ANY POWER FAILURES BUT DID NOT FIND ANYTHING VISUALLY. HE CONTINUED TO TROUBLESHOT AND FOUND THE POWER OUTAGE TO CAME FROM THE CABLE CONNECTION ON JP1 AND HE REPLACED SOLENOID DRIVER BOARD. HE REMOVED THE CABLE AND FOUND A LOSE WIRE IN THE CABLE. HE RETURNED WITH A NEW CABLE, REPLACED DAMAGED CABLE AND FOUND THIS TO BE THE ONE CAUSING THE PRESSURE AND VACUUM ISSUES). UPON INSTALLATION OF THIS CABLE HE WAS ABLE TO GET GOOD PRESSURE, AND VACUUM, BUT THERE WAS STILL A VACUUM LEAK. HE DISASSEMBLED THE PUMP AND COMPRESSOR AND REPLACED ALL VACUUM((D004-00-0058) AND PRESSURE HOSES(D004-00-0051) INCLUDING THE NYLON CONNECTORS FROM THE COMPRESSOR HOUSING. HE REASSEMBLED THE UNIT AND WAS ABLE TO PULL A GOOD VACUUM WITH NO LEAKS IN SIGHT. HE PERFORMED A FULL PM PER MANUFACTURE SPECIFICATIONS, DURING PM INSPECTION HE FOUND THE PRINTER TO NOT BE WORKING, PER CUSTOMERS APPROVAL HE REPLACED THE PRINTER ASSEMBLY(D161-00-0022). UNIT HAS PASSED ALL TEST AND CALIBRATIONS AND IS NOW READY FOR CLINICAL USE. HE REPLACED THE BATTERIES AS PART OF THE PM INTERVAL AND NOT THE REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD NOTIFIED MAINTENANCE CODE 1 ALARM. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258122 CS100,ENGLISH,NON-UTS,DOM SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3013-53 10607567107394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown