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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW SL MULTIPARAMETER MODULE

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SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW SL MULTIPARAMETER MODULE Back to Search Results
Model Number 91496
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Tachycardia (2095)
Event Date 12/21/2018
Event Type  malfunction  
Manufacturer Narrative
Spacelabs has been unable to validate this complaint or to conduct an investigation into this matter due to the lack of data available for inspection. There have been no further complaints reported by this customer. This report is complete and this particular issue is considered closed.
 
Event Description
Spacelabs received a report on (b)(6) 2018 that a patient monitor alarmed for tachycardia, but the hospital¿s nursing staff feel that the alarm should have been for ventricular tachycardia. No injury was reported associated with this issue.
 
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Brand NameSPACELABS ULTRAVIEW SL COMMAND MODULE
Type of DeviceULTRAVIEW SL MULTIPARAMETER MODULE
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
35301 se center st.
snoqualmie WA 98065
Manufacturer Contact
beth benner rn
35301 se center st.
snoqualmie, WA 98065
4253635568
MDR Report Key8253269
MDR Text Key133336661
Report Number3010157426-2019-00004
Device Sequence Number1
Product Code DSI
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
K103142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,01/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number91496
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received12/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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