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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. MEDEX LOGICAL PRESSURE MONITORING SYSTEM; PRESSURE MONITORING (AIR/GAS) KIT

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SMITHS MEDICAL INTERNATIONAL, LTD. MEDEX LOGICAL PRESSURE MONITORING SYSTEM; PRESSURE MONITORING (AIR/GAS) KIT Back to Search Results
Catalog Number MX960P1CZ
Device Problems High Readings (2459); Low Readings (2460)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2022
Event Type  malfunction  
Event Description
It was reported that the monitor reading differ between n1bp and 1bp is out of range.Ibp value is different form the n1bp value.
 
Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found no physical markings or damage noted on the returned unit.Functional testing found the device meets specifications.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.
 
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Brand Name
MEDEX LOGICAL PRESSURE MONITORING SYSTEM
Type of Device
PRESSURE MONITORING (AIR/GAS) KIT
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
olomoucka 306
hranice 1, mesto 753 0 1
EZ  753 01
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
olomoucka 306
hranice 1, mesto 753 0 1
EZ   753 01
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key14365170
MDR Text Key291829880
Report Number3012307300-2022-08578
Device Sequence Number1
Product Code PXE
Combination Product (y/n)N
Reporter Country CodeTC
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/06/2022
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 NumberMX960P1CZ
Device Lot Number4227294
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/13/2022
Initial Date FDA Received05/11/2022
Supplement Dates Manufacturer Received08/08/2022
Supplement Dates FDA Received09/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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