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U.S. Department of Health and Human Services

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

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SPACELABS HEALTHCARE (WASHINGTON), INC ULTRAVIEW SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number 90496
Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  malfunction  
Event Description
Could not obtain a cuff blood pressure on this patient on the monitor or on the monitor from adjacent bedspace. Had to call biomed to troubleshoot to fix it. No patient harm. In-house biomed team: spacelabs module 90496 #1: customer reported bp (blood pressure) not working. Ran functional bp tests, unsuccessful after several attempts. Switched bp hose and successfully passed tests. Verified proper operation and returned to service. Adjacent bedspace monitor: spacelabs module 90496 #2: customer reported bp not working. Ran functional bp tests and successfully passed on first attempt.
 
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Brand NameULTRAVIEW
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
SPACELABS HEALTHCARE (WASHINGTON), INC
35301 se center st
snoqualmie WA 98065
MDR Report Key11588216
MDR Text Key242913450
Report Number11588216
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 03/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number90496
Device Catalogue Number700-0029-00
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 FDA03/26/2021
Event Location Hospital
Date Report to Manufacturer03/30/2021
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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