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

Model Number	MX960
Medical Device Problem Code	Defective Device (2588)
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 cannot return to zero, has excessive drift and can not read data.No patient injury reported.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.Twenty five units were 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 hole in the diaphragm and a missing pin in the connector and was unable to be functionally tested.Twenty-one of the remaining quantity was found to be missing a plated insert from the connector or missing a pin in the connector.With the pin insert missing the mating connector pin is too small to make contact with the connector pins on the transducer so no connection or intermittent connection is possible.The last three units appeared to have no physical damage.During functional testing, all units failed.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 three units not missing inserts/pins, one was a borderline failure on internal testing, one had a cracked sensor, and one had no issues noted and was unable to determine reason for failure but appears to be a sensor failure.All transducers are 100 percent functional prior to assembly release.Additional investigation consisted of reviewing complaint database for similar failure modes to product code and determined there was an additional investigation 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.The supplier was contacted about 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 customers, suspect end user fault.

• 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: 16865980
• Report Number: 3012307300-2023-05028
• Device Sequence Number: 20322975
• 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: Other
• 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: 3932751
• 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: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2020
• 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