MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V MEDEX TRANSTAR PRESSURE TRANSDUCER; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Catalog Number	MX950
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9616567-2025-00046-00.The date of that submission was 21-nov-2025.H3/h6: one used set was received for evaluation.During visual inspection, the white cord near the phone jack was observed to be twisted.The functional testing was performed.The transtar of the monitoring kit was electrically tested per sop.X.2500-0038.The transtar was connected to a monitor and a 100 mmhg dead weight tester (p-2e-021; exp: 01/2030).The transtar was not able to be zeroed, and no waveform was able to be obtained.However, when tested for resistance), the sample failed the test.The probable cause of no readings had occurred due to the white cord being twisted near the phone jack.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Event or Problem Description
It was reported that the transducer was displaying intracranial pressure (icp) readings of 25-45mmgh.The patient received treatment for the increased icp readings including medications and a head computed tomography (ct).The elevated readings were not correlating with the clinical presentation of the patient.It was unsure if an actual harm was done to the patient.It was also noted after the questionable transducer was changed out that the wiring harness which runs from the plug to the transducer was twisted.There was no patient harm/adverse event.

• Brand Name: MEDEX TRANSTAR PRESSURE TRANSDUCER
• Common Device Name: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 24535294
• Report Number: 1526863-2026-00061
• Device Sequence Number: 10343319
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: (01)10351688503992(17)270311(10)4456599
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K942377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MX950
• Device Lot Number: 4456599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown