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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; PROBE, BLOOD-FLOW, EXTRAVASCULAR
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SMITHS MEDICAL ASD, INC. MEDEX; PROBE, BLOOD-FLOW, EXTRAVASCULAR Back to Search Results
Model Number MX9505T
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2021
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical probe sensor was implicated in the following event: the patient underwent aortic valve mechanical valve replacement under general anesthesia.The pressure sensor was connected to measure the central arterial pressure, and the transducer was found to be ruptured.The pressure sensor was replaced.There were no reported adverse events.
 
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Brand Name
MEDEX
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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key12217406
MDR Text Key263134607
Report Number3012307300-2021-07565
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 user facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMX9505T
Device Lot Number4072632
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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