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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/18/2019
Event Type  Malfunction  
Manufacturer Narrative

Spacelabs has initiated an investigation into this matter. A supplemental report will be filed once the investigation is complete.

 
Event Description

Spacelabs received a report on (b)(6) 2019 that the twelve-lead ecg analysis report from a patient monitor showed ecg tracing that appeared inconsistent when compared to twelve-lead reports from another manufacturer''s ecg recorder.

 
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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
marc rivas
35301 se center st.
snoqualmie, WA 98065
4253635568
MDR Report Key8899767
MDR Text Key154724937
Report Number3010157426-2019-00030
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK103142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 01/01/2005,06/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number91496
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
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 Received01/14/2005
Was Device Evaluated By Manufacturer? Yes
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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