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

Catalog Number	MX960
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 100mmhg test fails, 100mmhg±3 is specified, and the actual measured value reaches 1000mmhg.Device did not pass the pressure value test, there was a discrepancy.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
E1: (b)(6).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
H3 and h6.Codes: updated.The device received was clean in appearance with no physical damage noted.The reported problem of failure of 100mmhg test fails could not be confirmed as functional testing could not replicate the problem on the returned unit.The reported problem could not be confirmed.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: 19477551
• Report Number: 1526863-2024-00044
• Device Sequence Number: 19816164
• Product Code: DRS
• UDI-Device Identifier: 10351688502988
• UDI-Public: (01)10351688502988(17)340125(10)4455819
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• 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: 4455819
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/07/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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