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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR PRESSURE TRANSDUCER; PROBE, BLOOD-FLOW, EXTRAVASCULAR
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SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR PRESSURE TRANSDUCER; PROBE, BLOOD-FLOW, EXTRAVASCULAR Back to Search Results
Catalog Number MX9505T
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2024
Event Type  malfunction  
Manufacturer Narrative
H3: other; device not returned to manufacturer.Device evaluation: no product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
 
Event Description
It was reported that the arterial pressure sensor does not have a waveform after it is connected and cannot be used.It was then replaced with a new one.There was patient involvement and no patient harm/adverse event reported.
 
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Brand Name
MEDEX TRANSTAR PRESSURE TRANSDUCER
Type of Device
PROBE, BLOOD-FLOW, EXTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6250 shier rings road
dublin OH 43016
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key19066685
MDR Text Key339954152
Report Number1526863-2024-00022
Device Sequence Number1
Product Code DPT
UDI-Device Identifier10351688503992
UDI-Public(01)10351688503992(17)251003(10)4328512
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 04/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMX9505T
Device Lot Number4328512
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received04/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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