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

Model Number	MX960
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pressure transducer readings had a constant drift during use.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Unit inspected on receipt and appears to be assembled correctly.No physical damage on returned sample.Unit tested per internal procedures and met specifications.Unable to duplicate failure.The root cause cannot be established as no fault was found.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: MEDEX LOGICAL PRESSURE MONITORING SYSTEM
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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; minneapolis, MN 55442
• MDR Report Key: 15439296
• Report Number: 3012307300-2022-19483
• Device Sequence Number: 20252127
• Product Code: DRS
• UDI-Device Identifier: 10351688502988
• UDI-Public: 10351688502988
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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 Model Number: MX960
• Device Catalogue Number: MX960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown