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

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.

• Brand Name: MEDEX LOGICAL CABLE
• Type of Device: PRESSURE MONITORING (AIR/GAS) KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 14378600
• MDR Text Key: 291629144
• Report Number: 3012307300-2022-08682
• Device Sequence Number: 1
• Product Code: PXE
• Combination Product (y/n): N
• Reporter Country Code: AE
• Number of Events Reported: 1
• 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 Number: MX961Y68
• Device Lot Number: 4721V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/12/2022
• 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 Number: 1