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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL MEDEX LOGICAL CABLE; PRESSURE MONITORING (AIR/GAS) KIT

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NULL MEDEX LOGICAL CABLE; PRESSURE MONITORING (AIR/GAS) KIT Back to Search Results
Catalog Number MX961Y68
Device Problems High Readings (2459); Low Readings (2460)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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.
 
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Brand Name
MEDEX LOGICAL CABLE
Type of Device
PRESSURE MONITORING (AIR/GAS) KIT
Manufacturer (Section G)
NULL
MDR Report Key14378600
MDR Text Key291629144
Report Number3012307300-2022-08682
Device Sequence Number1
Product Code PXE
Combination Product (y/n)N
Reporter Country CodeAE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/12/2022
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 NumberMX961Y68
Device Lot Number4721V
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/13/2022
Initial Date FDA Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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