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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 Problems Fracture (1260); Incorrect, Inadequate or Imprecise Result or Readings (1535); Tear, Rip or Hole in Device Packaging (2385); Erratic Results (4059)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Event Description
It was reported that no data can be detected, packaging is damaged, connector is damaged, the data is out of order, which makes the product ineffective.There was patient involvement and no patient/adverse event reported.
 
Manufacturer Narrative
B3: the event occurred in various dates from (b)(6) 2023 to (b)(6) 2024.H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
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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 43016
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key19052043
MDR Text Key339497701
Report Number1526863-2024-00019
Device Sequence Number1
Product Code DPT
UDI-Device Identifier10351688503992
UDI-Public(01)10351688503992(17)250620(10)4287661
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 04/04/2024
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 Number4287661
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/07/2024
Initial Date FDA Received04/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2022
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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