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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL MEDEX LOGICAL KITS; PRESSURE MONITORING
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NULL MEDEX LOGICAL KITS; PRESSURE MONITORING Back to Search Results
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2022
Event Type  malfunction  
Manufacturer Narrative
Udi in section model# and device serial number/lot number are unknown.Device expiration date and device manufacturing date not available.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that the transducers will not allow a continuous flush to pass through the transducer.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
 
Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.No lot number was provided; therefore, dhr (device history review) could not be performed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.
 
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Brand Name
MEDEX LOGICAL KITS
Type of Device
PRESSURE MONITORING
Manufacturer (Section G)
NULL
MDR Report Key15737788
MDR Text Key307106408
Report Number3012307300-2022-26779
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 Foreign,User Facility
Reporter Occupation Nurse Practitioner
Type of Report Initial,Followup
Report Date 11/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/14/2022
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
Patient Sequence Number1
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