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

Catalog Number	MX960
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Zero (1683); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - phone number: (b)(6).H3 - other: device has not been returned to date.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.
Event or Problem Description
It was reported that the "pressure plate zero is not within 100±3.The p1 p2 p3 p4 value shows 196-197.The port is not in good contact and cannot be connected.The pressure value is displayed as 1067-1066; which is marked as 100±3." there was no patient involvement reported and no harm/adverse event reported.
Additional Manufacturer Narrative
Correction-d9 - date returned to mfg-5/2/2024 one device was returned for evaluation.Visual inspection does not show any signs of physical damage.Functional testing failed to meet specifications for multiple test specification criteria.Additional evaluation completed by dis-assembly of the two halves of the transducer housings to visually inspect internal assembly of the transducer, it was found to have incomplete solder application on one of the input impedance connections to the pc board allowing intermittent connection.Problem for port is not in good contact and cannot be connected was unable to be replicated.The customer's problem was confirmed.The root cause was the manufacturing assembly process for solder application.No further actions.The device history review of the reported lot number found no non-conformities during the manufacturing process.

• 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: 19119270
• Report Number: 1526863-2024-00024
• Device Sequence Number: 8359843
• Product Code: DRS
• UDI-Device Identifier: 10351688502988
• UDI-Public: (01)10351688502988(17)330820(10)4422966
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 4422966
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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