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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. ULTRAVIEW 1050 DETECTOR AND ALARM, ARRHYTHMIA

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SPACELABS HEALTHCARE INC. ULTRAVIEW 1050 DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number 90369
Device Problem Device Alarm System (1012)
Patient Problem No Information (3190)
Event Date 10/23/2016
Event Type  malfunction  
Event Description
Unit did not alarm during asystole, both on the unit and the central station.
 
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Brand NameULTRAVIEW 1050
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
35301 s.e. center st.
snoqualmie WA 98065
MDR Report Key6188538
MDR Text Key62824624
Report Number6188538
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/15/2016,12/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2016
Is this a Product Problem Report? Yes
Device Operator
Device Model Number90369
Device Catalogue Number20099967
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/15/2016
Event Location Hospital
Date Report to Manufacturer11/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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