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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR PRESSURE MONITORING SYSTEM; PROBE, BLOOD-FLOW, EXTRAVASCULAR
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SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR PRESSURE MONITORING SYSTEM; PROBE, BLOOD-FLOW, EXTRAVASCULAR Back to Search Results
Model Number MX9505T
Device Problem Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  malfunction  
Manufacturer Narrative
No device was returned for evaluation.
 
Event Description
It was reported that there was no data is collected.No patient injury.
 
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Brand Name
MEDEX TRANSTAR PRESSURE MONITORING SYSTEM
Type of Device
PROBE, BLOOD-FLOW, EXTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6250 shier rings road
dublin OH 43016
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6250 shier rings road
dublin OH 43016
Manufacturer Contact
jim vegel
6000 nathan lane north
yuexiu district
minneapolis, MN 55442
MDR Report Key14137622
MDR Text Key289464036
Report Number3012307300-2022-06549
Device Sequence Number1
Product Code DPT
UDI-Device Identifier10351688503992
UDI-Public10351688503992
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K942377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMX9505T
Device Catalogue NumberMX9505T
Device Lot Number4143097
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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