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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 Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 05/22/2021
Event Type  Malfunction  
Manufacturer Narrative

Spacelabs has launched an investigation and will file a supplemental report when the investigation is complete.

 
Event Description

Spacelabs received a report that on (b)(6) 2021 the customer informed that a monitor 13 (xprezzon) on acc, alleged failed to audio alarm when a patient was presenting with a vt arrhythmia. It was confirmed that the bezel of the monitor did give a yellow medium indicator. ¿ no injury was reported associated with this event.

 
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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 Key11980313
MDR Text Key258919137
Report Number3010157426-2021-00034
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
Type of Report Initial,Followup
Report Date 01/01/2005,08/27/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/10/2021
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? Yes
Is The Reporter A Health Professional? No
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 Received05/22/2021
Was Device Evaluated By Manufacturer? No Answer Provided
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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