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

Model Number	MX960
Medical Device Problem Code	Inappropriate Waveform (2536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that no waveforms were showing.No additional information.
Additional Manufacturer Narrative
Other text: additional information: h6 and h10.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.No manufacturing or service issues were identified as causes of the customer's reported problem during the review of service and repair records.Six units returned for investigation.Each unit had markings in black marker and/or tape as returned.Each unit was visually inspected using 10x magnification for physical damage with the following results: one unit found to be missing plated pin insert connecting to an output pin.One unit found to be missing plated pin insert connecting to an output pin along with missing plated insert pin for drain.Three unit found to be missing plated pin insert connecting to an input pin.One unit found to be missing output pin.Unable to do functional test.Functional test: five of the returned units were tested per internal test specification.Each unit failed the input or output impedance corresponding to the pin insert missing.To determine if the missing insert was the reason for failure a manual continuity test was completed on each unit, and each passed the input and output resistance testing.With the pin insert missing the mating connector pin is too small to contact the connector pins on the transducer.The reported issue was confirmed.Additional investigation: reviewed complaint database and found no additional complaints for the lot numbers returned.Reviewed internal non-conformance for supplier issues related to purchased connector, no issues noted relating to issue found.Manually tried to pull pin inserts out of the transducer connector pins from returned units using a mating cable connector but was unable to duplicate issue after multiple connections.Tried pulling inserts out with a pin gauge and was able to duplicate pull inserts out.Unable to determine the amount of usage prior to the inserts being pulled out of the connector although each unit appears to have been used prior to issue detected based on the writing on the units.No corrective actions are planned at this time but will trend for future actions if required.The root cause remains undetermined.

• Brand Name: MEDEX LOGICAL TRANSDUCERS
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; jiangdong street; minneapolis, MN 55442
• MDR Report Key: 13367668
• Report Number: 3012307300-2022-01933
• Device Sequence Number: 5304054
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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
• Device Lot Number: ML527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 05/26/2023
• 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