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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE (WASHINGTON), INC ULTRAVIEW SL SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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SPACELABS HEALTHCARE (WASHINGTON), INC ULTRAVIEW SL SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number 91496
Device Problems Circuit Failure (1089); No Display/Image (1183); Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 02/09/2021
Event Type  malfunction  
Event Description
During admission, we went through 3 blood pressure (bp) cables and tried on two different cartridges to obtain a blood pressure and the monitor kept shorting out and the screen kept going blank. We tried to troubleshoot wires and cords to see if something was loose and even physically moved the monitor, but eventually (and after a few hours of randomly going out) it worked. No patient harm. Biomed in-house findings; customer reported unable to take bp. Ran functional bp tests using a patient simulator with no issues. Verified proper operation of the device and returned to service.
 
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Brand NameULTRAVIEW SL
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
SPACELABS HEALTHCARE (WASHINGTON), INC
35301 se center
snoqualmie WA 98065
MDR Report Key11347874
MDR Text Key232543098
Report Number11347874
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2021
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 Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2021
Event Location No Information
Date Report to Manufacturer02/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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