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U.S. Department of Health and Human Services

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

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SPACELABS HEALTHCARE (WASHINGTON), INC TRULINK SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number 90496
Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 02/05/2021
Event Type  malfunction  
Event Description
Monitor unable to capture blood pressure despite changing cuff, box and cable. No patient harm. Biomed evaluation in-house: found inflation error when trying to test nibp (non-invasive blood pressure) because of leaky bp hose. Replaced with known working bp hose. Successfully tested nibp.
 
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Brand NameTRULINK
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
SPACELABS HEALTHCARE (WASHINGTON), INC
35301 se center street
snoqualmie WA 98065
MDR Report Key11347884
MDR Text Key232546689
Report Number11347884
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 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 FDA02/11/2021
Event Location Hospital
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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