MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX LOGICAL TRANSDUCER MOUNTING PLATE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	MX960
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pressure sensor did not respond after being connecting to the sensor board and the pressure value could not be detected.After replacing the pressure sensor board with a new one, the display appeared.This reportedly occurred with 43 pressure sensors.There was no patient involvement reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
After further review, this was found to be a non-reportable event.The event does not meet the definition of a reportable death or serious injury as the malfunction of the device did not cause or contribute to a patient death, a life-threatening event, permanent impairment of a body function or structure, required medical or surgical intervention to preclude serious impairment of a body structure or function.Additionally, the reportable malfunctions list indicates that the device in the reported incident would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, mfr#1526863-2024-00003-00 will be cancelled.

• Brand Name: MEDEX LOGICAL TRANSDUCER MOUNTING PLATE
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18563132
• Report Number: 1526863-2024-00003
• Device Sequence Number: 18188520
• Product Code: DRS
• UDI-Device Identifier: 10351688502988
• UDI-Public: 10351688502988
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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: Other
• Device Catalogue Number: MX960
• Device Lot Number: 4027697
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2023
• Supplement Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2020
• 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