BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW COMMAND MODULE

    MDR report key: 4244166 · Received November 11, 2014

    Report

    Report Number
    3010157426-2014-00069
    Event Type
    Death
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    November 11, 2014
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONSITE TESTING OF THE INVOLVED DEVICES ON OCTOBER 17, 2014 BY A FSE CONFIRMED THAT THE EQUIPMENT WORKED TO SPECIFICATIONS. THE TESTING WAS WITNESSED BY A FACILITY STAFF MEMBER. ADDITIONALLY, THE CUSTOMER STATED THE NURSE INVOLVED IN THE EVENT ¿MADE CHANGES TO THE MONITOR SETTINGS DURING THE ALLEGED EVENT TIME PERIOD.¿ THE HOSPITAL RISK MANAGER DECLINED TO PROVIDE ANY HISTORICAL INFORMATION FOR A SPACELABS EVALUATION OF THE EVENT STATING THEIR INTERNAL INVESTIGATION DID NOT INDICATE ANY EQUIPMENT MALFUNCTION. IN THE INTERVAL BETWEEN THE EVENT AND SPACELABS NOTIFICATION, THE INVOLVED HOSPITAL MONITOR SOFTWARE WAS UPDATED, WHICH ERASES ANY PREVIOUSLY STORED PATIENT RECORDS. THE CUSTOMER DOES NOT HAVE THE SPACELABS ICS PRODUCT, WHICH WOULD PROVIDE RETROSPECTIVE DATA; THEREFORE, IT IS NOT POSSIBLE TO REVIEW PATIENT DATA AT THE TIME OF THE EVENT. THE HOSPITAL REFUSED TO PROVIDE ANY EVENT DATA. THESE FACTORS PREVENT A SPACELABS DETERMINATION OF ROOT CAUSE FOR THE ALLEGED PRODUCT FAILURE. THE CUSTOMER CONTINUES TO USE THE INVOLVED DEVICES ON PATIENTS, AND HAS ADVISED SPACELABS THAT IT IS SATISFIED VIA ITS OWN INTERNAL INVESTIGATION THAT THERE WAS NO SPACELABS EQUIPMENT MALFUNCTION. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ONSITE TESTING OF THE INVOLVED DEVICES ON (B)(4) 2014 BY A FSE CONFIRMED THAT THE EQUIPMENT WORKED TO SPECIFICATIONS. THE TESTING WAS WITNESSED BY A FACILITY STAFF MEMBER. ADDITIONALLY, THE CUSTOMER STATED THE NURSE INVOLVED IN THE EVENT ¿MADE CHANGES TO THE MONITOR SETTINGS DURING THE ALLEGED EVENT TIME PERIOD.¿ THE HOSPITAL RISK MANAGER DECLINED TO PROVIDE ANY HISTORICAL INFORMATION FOR A SPACELABS EVALUATION OF THE EVENT STATING THEIR INTERNAL INVESTIGATION DID NOT INDICATE ANY EQUIPMENT MALFUNCTION. IN THE INTERVAL BETWEEN THE EVENT AND SPACELABS NOTIFICATION, THE INVOLVED HOSPITAL MONITOR SOFTWARE WAS UPDATED, WHICH ERASES ANY PREVIOUSLY STORED PATIENT RECORDS. THE CUSTOMER DOES NOT HAVE THE SPACELABS ICS PRODUCT, WHICH WOULD PROVIDE RETROSPECTIVE DATA; THEREFORE, IT IS NOT POSSIBLE TO REVIEW PATIENT DATA AT THE TIME OF THE EVENT. THE HOSPITAL REFUSED TO PROVIDE ANY EVENT DATA. THESE FACTORS PREVENT A SPACELABS DETERMINATION OF ROOT CAUSE FOR THE ALLEGED PRODUCT FAILURE. THE CUSTOMER CONTINUES TO USE THE INVOLVED DEVICES ON PATIENTS, AND HAS ADVISED SPACELABS THAT IT IS SATISFIED VIA ITS OWN INTERNAL INVESTIGATION THAT THERE WAS NO SPACELABS EQUIPMENT MALFUNCTION THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED. NOTE: DATE OF OCCURRENCE: (B)(6) 2014. PLACEHOLDER.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A BEDSIDE PATIENT MONITOR, MODEL 90364 WITH COMMAND MODULE MODEL 90496, FAILED TO ALARM AND HAD A 15 MINUTE GAP IN DATA. THE EVENT OCCURRED IN THE AFTERNOON OF (B)(6), 2014. IT IS NOT KNOWN IF THE PATIENT PASSED AWAY DURING THE EVENT OR AT A DIFFERENT TIME.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A BEDSIDE PATIENT MONITOR, MODEL 90364 WITH COMMAND MODULE MODEL 90496, FAILED TO ALARM AND HAD A 15 MINUTE GAP IN DATA. THE EVENT OCCURRED IN THE AFTERNOON OF (B)(6) 2014. IT IS NOT KNOWN IF THE PATIENT PASSED AWAY DURING THE EVENT OR AT A DIFFERENT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727806 SPACELABS ULTRAVIEW COMMAND MODULE ULTRAVIEW MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 90496

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 90364((B)(4))V1.03.10| 90364 ((B)(4))V1.03.10