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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. MERITRANS DTXPLUS SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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MERIT MEDICAL SINGAPORE PTE LTD. MERITRANS DTXPLUS SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number 682000
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2021
Event Type  malfunction  
Manufacturer Narrative
The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that during the hemodynamic monitoring of a patient, the pressure monitoring [pm] set was found to be leaking fluid close to the planecta. Replaced with a new unit. No patient injury to report.
 
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Brand NameMERITRANS DTXPLUS
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, sgp 76892 6
SN 768926
Manufacturer (Section G)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, sgp 76892 6
SN 768926
Manufacturer Contact
bryson heaton
1600 merit parkway
south jordan, UT 84095
8012084662
MDR Report Key11446737
MDR Text Key248267951
Report Number8020616-2021-00010
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K935782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number682000
Device Catalogue Number688037/JPB
Device Lot NumberC1972419
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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