BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MONITORING KIT

    MDR report key: 168965 · Received May 15, 1998

    Report

    Report Number
    1713468-1998-00041
    Event Type
    Malfunction
    Date Received
    May 15, 1998
    Date of Event
    April 1, 1998
    Report Date
    April 16, 1998
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DRS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A TRANSPAC IV TRANSDUCER SAMPLE WAS RECEIVED FOR ANALYSIS. THE TRANSDUCER WAS VISUALLY INSPECTED ON THE CONNECTOR TO DETERMINE IF THE CONDUCTORS HAD BEEN EXPOSED TO MOISTURE. THERE WAS NO EVIDENCE OF THIS. THE TRANSDUCER WAS ATTACHED TO A PHYSIO CONTROL MONITOR AND WAS FOUND TO PERFORM PROPERLY. MONITOR READINGS: AT 0 MMHG PRESSURE: 0MMHG, ZERO PRESSURE RANGE: -01 - +01MMHG, AT 100 MMHG PRESSURE: 100MMHG, 100MMHG PRESSURE RANGE: 99 - 101MMHG. ADDITIONALLY, THE UNIT WAS TESTED FOR ELECTRICAL PERFORMANCE AND WAS FOUND TO MEET PRODUCT RELEASE SPECIFICATIONS AS EVIDENCED BY THE FOLLOWING RESULTS: INPUT IMPEDANCE: RESULT 2592 OHMS, SPECIFICATION 1800-4500 OHMS. OUTPUT IMPEDANCE: RESULT 305 OHMS, SPECIFICATION 270-330 OHMS. SENSITIVITY: RESULT 4.983 MV/V/MMHG, SPECIFICATION SENSITIVITY LIMITS: 4.960-5.060MV/V/MMHG. THE TRANSDUCERS ARE 100% TESTED DURING THE MANUFACTURING PROCESS FOR ELECTRICAL ATTRIBUTES. IN ADDITION, IN-PROCESS QUALITY PERSONNEL PERFORM A TEST ON A REPRESENTATIVE SAMPLING TO SIMULATE USE AND HANDLING IN ORDER TO DETECT NON-CONFORMANCES. THE CAUSE FOR THE REPORT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORT RECEIVED OF UNDOCUMENTED NUMBER ("MANY") OF UNDOCUMENTED INCIDENTS INVOLVING LOSS OF PRESSURE WAVEFORMS AND READINGS WITH THE DISPOSABLE TRANSDUCERS OCCURRING OVER THE LAST 2-4 MONTHS. THIS HAS BEEN REPORTED FROM THE OPERATING ROOM (OPEN HEART SURGERY) AND FROM THE INTENSIVE CARE UNIT. THE CONNECTION FROM THE TRANSDUCER TO THE MONITOR CABLE APPEARS TO BE A TIGHT FIT, AND THE EXPECTED "CLICK" IS HEARD UPON CONNECTION. THE VALUES AND WAVEFORMS, HOWEVER, WILL "INTERMITTENTLY DISAPPEAR AND REAPPEAR IF THE CABLE/CONNECTION IS WIGGLED OR ROCKED." THIS SEEMS TO OCCUR MOSTLY WITH RADIAL ARTERIAL LINES. SURGERY HAS HAD EXPERIENCES WHERE THE WAVEFORM HAS COMPLETELY DISAPPEARED AND COULD NOT BE RE-ESTABLISHED RESULTING IN LOSS OF DYNAMIC BLOOD PRESSURE INFO DURING THE PROCEDURE. THE PRESSURE CABLES WERE REPLACED IN ALL INCIDENTS, BUT THIS DID NOT RESOLVE THE PROBLEM. NO REPORTS OF ANY ADVERSE PT EVENTS DUE TO THIS ISSUE HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM MONITORING KIT PRESSURE MONITORING KIT DRS ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other HEWLITT PACKARD MERLIN MONITORS.| TRANSDUCER CABLES.