BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19949364 · Received August 9, 2024

    Report

    Report Number
    2249723-2024-03222
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 19, 2024
    Report Date
    January 21, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS : D4 # UDI , B5, B6, B7,H8,H6 ( HEALTH EFFECT ¿ CLINICAL CODE, HEALTH EFFECT ¿ IMPACT CODES). UPDATED FIELDS: B4,D8, D9, G3, G6, H2,H3,H4, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE), H11, THE FSE VERIFIED THE REPORTED THROUGH A PHOTO AND ORDERED THE REQUIRED PARTS AND WAS ABLE TO REPAIR AND REPLACE WHEEL ASSY. THERE WAS NO PATIENT INVOLVEMENT AND THE ISSUE IS RESOLVED. PERFORMED ALL FUNCTIONAL AND SAFETY TESTS ON THE UNIT. THE UNIT WAS APPROVED FOR CLINICAL USE AND RETURNED TO THE USER. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE PART NUMBER: 0997-00-0588 SERIAL NUMBER: N/A WITH A REPORTED UNIT FAILURE OF THE WHEEL AXLE DAMAGED DUE TO THE HARSH SURFACE USED ON. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED VISUAL INSPECTION OF THE PART RECEIVED P/N: 0997-00-0588 SERIAL NUMBER: N/A WHEEL ASSY AND FOUND THAT THE PART IS BROKEN. THE ROOT CAUSE OF THE BROKEN WHEEL AXLE IS THE HARSH ENVIRONMENT USED ON. DUE TO THIS DAMAGE. THIS PART CANNOT BE INVESTIGATED ANY FURTHER BY THE FAT DEPT. THE FAILURE ANALYSIS AND TESTING DEPARTMENT VERIFIED THE BROKEN WHEEL AXLE. RETAINING THE PART IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV. AS. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE IS "NORMAL WEAR AND TEAR".

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER DURING AN UNRELATED SERVICE, THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WHEELS FOR TRANSPORT UNIT FOR THE HELICOPTER SERVICE WERE BROKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER DURING AN UNRELATED SERVICE, THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WHEELS FOR TRANSPORT UNIT FOR THE HELICOPTER SERVICE WERE BROKEN.THERE WAS NO PATIENT INVOLVEMENT REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514545 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown