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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 Device Operates Differently Than Expected (2913)
Patient Problems Arrhythmia (1721); Ventricular Fibrillation (2130)
Event Date 01/26/2017
Event Type  Malfunction  
Manufacturer Narrative

The spacelabs field service engineer made several attempts to follow up with the customer for additional information, but was unsuccessful. When on site, the field service engineering was unable to access the equipment for testing because the device continued to be used to monitor patients. Because the event was reported to spacelabs 13 days after occurrence, at the time of investigation the patient's record had been purged from the ics database. Additionally, the customer was unable to provide any waveform recordings showing the complaint episode or other information. No recurrences have been reported. This report is complete, and this particular issue is considered closed.

 
Event Description

Spacelabs received a report that on (b)(6) 2017 that the monitor failed for vfib arrhythmia while in use. No patients were injured as a result of 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 Key6390025
MDR Text Key69761866
Report Number3010157426-2017-00025
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK103142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 03/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number91496
OTHER Device ID Number2.05.12
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/08/2017 Patient Sequence Number: 1
Treatment
91393
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