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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 Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2022
Event Type  malfunction  
Event Description
It was reported that the patient was hospitalized for sudden right limb weakness with vague mouth and teeth for 3 hours.It was found that there was more blood return at the abp end of the pipeline.The examination found that the pressure sensor was cracked and could not be used.
 
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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
minneapolis, MN 55442
MDR Report Key13995246
MDR Text Key288488479
Report Number3012307300-2022-05776
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
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
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 Number4184655
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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