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

Model Number	MX960
Medical Device Problem Codes	Display Difficult to Read (1181); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device would not return to zero, excessive drift, and unable to read data.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for e-complaint.Visual and functional testing were performed.No problems or issues were identified during this device history record review.One used decontaminated sample was received for investigation.Five units returned for investigation.Each unit had adhesive tape or sticker applied to the unit.Each unit was visually inspected under 10x magnification.One unit was found to have a missing pin in the connector and was unable to be functional tested.Two of the remaining quantity (4) found to be missing a plated insert from the connector.With the pin insert missing the mating connector pin was too small to make contact with the connector pins on the transducer.No connection or intermittent connection was possible.The last two units all appear to have no physical damage.Four units functional tested per internal test procedure.Two of the four units failed functional testing (see functional test data attachment rack positions 51-55, all complaints from same end user tested during one test run and included) of the units missing insert or pins, each unit failed corresponding to the insert or pin missing (either input or output).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.Of the two units not missing inserts, they met specification and unable to duplicate failure.Reviewed complaint database for similar failure modes to product code and determined there were additional investigations on multiple complaints from same customer with similar results of missing inserts or pins.Requested additional information from customer through product surveillance group for any information on use, cleaning, handling, etc., with no response to date.Also contacted the supplier of the purchased connector and there does not appear to be a change on the assembly process or amount of force required to remove insert.With no large occurrence of failures from other supplied, the root cause of the reported event was found to be suspect end user fault.No action was taken.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16872996
• Report Number: 3012307300-2023-05105
• Device Sequence Number: 17591453
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2023

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: 4018748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown