MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR SINGLE MONITORING KIT; PRESSURE MONITORING KITS

Model Number MX9505T

Device Problem Unable to Obtain Readings (1516)

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

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.Device history record of reported lot 4184654 was executed, and no discrepancies and deviations were observed.Reported lot was found conforming according to smiths medical requirements.

Event Description

It was reported that during a scheduled operation, the pressure sensor was used to monitor the arterial blood pressure.When the doctor was using it, they found that the connection of the pressure sensor was loose and falls off, which can not monitor the patient's arterial blood pressure.For the elderly, it may lead to serious medical accidents.In this event, the doctor was able to immediately replace the faulty device with a new pressure sensor to ensure the operation safety of the patient.No injury or adverse affects to the involved patient.

• Brand Name: MEDEX TRANSTAR SINGLE MONITORING KIT
• Type of Device: PRESSURE MONITORING KITS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; second ring road; minneapolis, MN 55442
• MDR Report Key: 14760405
• MDR Text Key: 302009678
• Report Number: 3012307300-2022-12318
• Device Sequence Number: 1
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: 10351688503992
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX9505T
• Device Catalogue Number: MX9505T
• Device Lot Number: 4184654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR