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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 High Sensing Threshold (2574)
Patient Problem Insufficient Information (4580)
Event Date 03/02/2021
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical pressure probe cannot detect central venous pressure (cvp).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
nanqiao new city, fengxian dis
minneapolis, MN 55442
MDR Report Key12042467
MDR Text Key257504332
Report Number3012307300-2021-06382
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 06/22/2021
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 Model NumberMX9505T
Device Lot Number4024478
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/24/2021
Initial Date FDA Received06/22/2021
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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