BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 4929159 · Received July 21, 2015

    Report

    Report Number
    3010157426-2015-00145
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    June 26, 2015
    Report Date
    August 19, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED PATIENT RETROSPECTIVE DATABASE WAS REVIEWED BY A SPACELABS SOFTWARE LEAD ENGINEER. THE FOLLOWING ALARMS WERE LOCATED IN THE DATABASE CONCURRENT WITH THE REPORTED EVENT: ON (B)(6) AT 03:41:18 A.M., A HIGH PRIORITY ALARM FOR ECG LOW RATE WAS INITIATED. DURATION OF THE ¿LOW RATE¿ ALARM CONDITION WAS 17 SECONDS. ON (B)(6) AT 3:41:44 A.M., MULTIPLE SEQUENTIAL HIGH PRIORITY ECG ALARMS WERE INITIATED. DURATION OF THIS ¿STACKED¿ ALARM CONDITION WAS 1,887 SECONDS (31 MINUTES). ON (B)(6) AT 4:13:14 A.M., A HIGH PRIORITY ALARM FOR ECG LOW RATE WAS INITIATED. DURATION OF THE ¿LOW RATE¿ ALARM CONDITION WAS 269 SECONDS (4 MINUTES). ON (B)(6) AT 4:19:46 A.M., A HIGH PRIORITY ALARM FOR ECG HIGH RATE WAS INITIATED. DURATION OF THE ¿HIGH RATE¿ ALARM CONDITION WAS 351 SECONDS (6 MINUTES). AS DOCUMENTED IN THE PRODUCT¿S OPERATIONS MANUAL, AUDIBLE AND VISUAL ALARM INDICATIONS ARE CONTINUOUSLY PRESENT AT THE BEDSIDE MONITOR THROUGHOUT AN ALARM CONDITION. FOR REMOTE ALARM SURVEILLANCE, ALARM WATCH AND REMOTE VIEW ALARMS WILL GENERATE A SINGLE TONE, ONE TIME ONLY, AT A REMOTE BEDSIDE MONITOR WITH THE ONSET OF THE ALARM CONDITION. ALTHOUGH VISUAL ALARM INDICATIONS WILL PERSIST REMOTELY THROUGHOUT AN ALARM CONDITION, THE ALARM TONE WILL NOT BE REPEATED REGARDLESS OF THE DURATION OF THE ALARM CONDITION. AS THE ALARM CONDITIONS IDENTIFIED IN THE COMPLAINT WERE APPROPRIATELY CLASSIFIED AND DOCUMENTED IN THE DATABASE AND THESE INDICATORS OPERATED ACCORDING TO SPECIFICATIONS WHEN TESTED BY A SPACELABS FIELD SERVICE ENGINEER, WE KNOW OF NO REASON THAT AUDIBLE AND VISUAL ALARM INDICATIONS WOULD NOT HAVE BEEN PRESENT AT THE BEDSIDE MONITOR AT THE TIME OF THE COMPLAINT EPISODE. HOWEVER, THERE IS NO RECORD OF THE USER SELECTABLE ALARM TONE VOLUME SETTING. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

    ONSITE TESTING OF THE INVOLVED DEVICES BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THAT ALL EQUIPMENT PERFORMED TO SPECIFICATION INCLUDING THE AUDIBLE ALARMS. TESTING WAS WITNESSED BY A FACILITY STAFF MEMBER. SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2015 AT 03:41 A.M., THE CLINICAL STAFF DID NOT HEAR AN AUDIBLE ALARM FROM A PATIENT BEDSIDE MONITOR MODEL 91369 WITH COMMAND MODULE 91496 UPON ENTERING THE PATIENT ROOM TO TREAT A CARDIAC EVENT. THE CARDIO-PULMONARY RESUSCITATION GIVEN THE PATIENT WAS SUCCESSFUL. THE EVENT OCCURRED IN A NEONATAL INTENSIVE CARE UNIT. AN OSCILLATOR VENTILATOR WAS ALSO RUNNING IN THE ROOM AND THE DOOR WAS OPEN AT THE EVENT TIME. THE CLINICAL STAFF ALSO REPORTED THAT THEY DID NOT HEAR THE ALARM WATCH AUDIBLE TONE FOR THE EVENT THAT WAS SET AT ANOTHER 91369 BEDSIDE MONITOR LOCATED OUTSIDE THE PATIENT¿S ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471534 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW SL MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening