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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LOGICAL PRESSURE TRANSDUCER; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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SMITHS MEDICAL ASD, INC. LOGICAL PRESSURE TRANSDUCER; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR Back to Search Results
Device Problem Incorrect Measurement (1383)
Patient Problem Death (1802)
Event Date 10/24/2018
Event Type  Death  
Manufacturer Narrative
Foreign: (b)(6).Reported user facility is (b)(6) hospital.Complaint source document was from a smiths medical company representative.
 
Event Description
Information was received that a smiths medical logical pressure transducer was connected to a monitor of an unknown brand and the monitor was seen to be reading an irregular pressure.To counter the reading, the staff administered medication.Subsequently, it was reported that harm was then done to the patient and that they later expired.
 
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Brand Name
LOGICAL PRESSURE TRANSDUCER
Type of Device
TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL CZECH REPUBLIC
olomoucká 306,
hranice 1 - mesto
hranice, 75301
EZ  
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key8108868
MDR Text Key128555931
Report Number3012307300-2018-08440
Device Sequence Number1
Product Code DRS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Date Manufacturer Received10/29/2018
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 N
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly; Death;
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