MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR SINGLE MONITORING KIT; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Catalog Number MX9505T

Device Problems Unable to Obtain Readings (1516); Calibration Problem (2890)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2023

Event Type  malfunction  

Event Description

It was reported that the patient was asked to replace the pressure sensor."the monitor showed that the arterial pressure could not be calibrated to zero despite being given calibration points.It still could not be detected".The patient was given a new pressure sensor and its display was normal.There was no patient adverse effect.

Manufacturer Narrative

Other text: 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.

• Brand Name: MEDEX TRANSTAR SINGLE MONITORING KIT
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18077090
• MDR Text Key: 327439536
• Report Number: 3012307300-2023-10273
• Device Sequence Number: 1
• Product Code: DPT
• UDI-Device Identifier: 10351688502919
• UDI-Public: 10351688502919
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K942377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MX9505T
• Device Lot Number: 4323141
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male