BEUDAMED
    FDA Adverse Event Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 3964688 · Received July 29, 2014

    Report

    Report Number
    3010157426-2014-00054
    Date Received
    July 29, 2014
    Date of Event
    June 29, 2014
    Report Date
    September 13, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS IS EVALUATING THIS REPORTED EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN OUR EVALUATION IS CONCLUDED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ONSITE TESTING OF THE INVOLVED DEVICES BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THE EQUIPMENT PERFORMED TO SPECIFICATIONS. THE TESTING WAS WITNESSED BY A FACILITY STAFF MEMBER. THE CUSTOMER PROVIDED THE PATIENT RETROSPECTIVE DATABASE, WHICH WAS REVIEWED BY A SPACELABS LEAD SOFTWARE ENGINEER. THE DATABASE CONFIRMED THE PATIENT HAD A PACEMAKER. FOR REFERENCE, SPACELABS¿ ECG ALGORITHM WILL IDENTIFY AS THE DOMINANT BEAT CLASS (NORMAL BEATS), THE FIRST NON-PACED BEAT THAT OCCURS TEN TIMES. IN THIS CASE, THE NORMAL BEAT CLASS THAT WAS IDENTIFIED CONTAINED A WIDE QRS WAVEFORM SIMILAR TO SOME VERSIONS OF VTACH. AT 11:36 P.M. ON (B)(6) 2014 THE PATIENT¿S RHYTHM SWITCHED FROM A PACED RHYTHM TO A NON-PACED RHYTHM WITH A WIDE QRS WAVEFORM - THE NORMAL DOMINANT BEAT CLASS FOR THIS PATIENT. THE MONITOR DID NOT ALARM FOR VTACH SINCE THE PATTERN, ALTHOUGH SIMILAR TO A VTACH PATTERN, DID NOT MEET THE SPACELABS PRODUCT CRITERIA FOR VTACH. THE SAME NON-PACED RHYTHM OCCURRED AT THE OTHER TWO EVENT TIMES NOTED BY THE CUSTOMER (5:06 A.M. AND 7:43 A.M. ON (B)(6) 2014). TO SUMMARIZE, WE HAVE CONCLUDED THAT THE MONITOR DID NOT MALFUNCTION. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE IS CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITOR, MODEL 91393, FAILED TO ALARM ON VENTRICULAR TACHYCARDIA(V-TACH). NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITOR XPREZZON MODEL 91393 WITH COMMAND MODULE MODEL 91496 FAILED TO GENERATE AND ALARM FOR THREE INSTANCES OF VENTRICULAR TACHYCARDIA (VTACH) AT 11:36 P.M. ON (B)(6) 2014 AND 5:06 A.M. AND 7:43 A.M. ON (B)(6) 2014. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442070 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW SL MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR