• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW SL MULTIPARAMETER MODULE Back to Search Results
Model Number 91496
Device Problem Device Alarm System (1012)
Patient Problems Death (1802); Ventricular Fibrillation (2130)
Event Date 12/06/2019
Event Type  Death  
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 december 6th, 2019 that on (b)(6) 2019 a patient went into a ventricular fibrillation heart rhythm. The customer reported that this heart rhythm was incorrectly categorized by the monitor as a pause, which is a medium priority alarm, instead of the high priority alarm that should have been generated for ventricular fibrillation. The customer reports that the patient subsequently died.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9548132
MDR Text Key173646639
Report Number3010157426-2019-00042
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
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,01/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2020
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 Received12/06/2019
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 01/03/2020 Patient Sequence Number: 1
-
-