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

Catalog Number	MX960
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	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.D4: expiration date and h4: manufacture date is not available based on the reported lot number.E1 - initial reporter phone: (b(6).Information becomes available.
Event or Problem Description
It was reported that it has a faulty connector, the pressure wave varies when cable plug is flexed.The reported product fault was detected during initial equipment checks prior to clinic starting.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9: date returned to mfg.: 4/2/2024 d4 - lot number, d4 - expiration date, d4 - unique identifier (udi), h4 - device mfg date, h3 and h6.Codes: updated.Received for investigation: one device with part number a960 and lot number 4258600.No visible damage noted on the returned unit.Simulated transducer/interface cable connection by mating to the transducer connector using a p1501-50 test cable, manually checked continuity through the cable using a multimeter, intermittent connection was found in the transducer connector.Functional tested the unit and the unit failed to meet specifications.The reported problem was confirmed and caused by intermittent connection in the transducer connector.Unable to determine what is causing the intermittent connection within the connector.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18937494
• Report Number: 1526863-2024-00014
• Device Sequence Number: 12505300
• Product Code: DRS
• UDI-Device Identifier: 10351688502988
• UDI-Public: (01)10351688502988(17)320306(10)4258600
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: MX960
• Device Lot Number: 4258600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 12/07/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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