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

Model Number	MX960
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Dhr review was done, no issues related to the original complaint were found.
Event or Problem Description
It was reported that there four devices have no data to read.No additional information.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Dhr review was done, no issues related to the original complaint were found.
Event or Problem Description
It was reported that there four devices have no data to read.No additional information.
Additional Manufacturer Narrative
Other, other text: 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.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: two were missing the plated pin insert connecting an output pin, one was missing an output pin along with missing plated insert pin for drain, the remaining were missing plated pin insert connecting to an input pin.During functional testing, 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 make contact with the connector pins on the transducer.During additional investigation, the complaint database was reviewed and there were 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 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.The root cause of the reported issue could not be determined.No corrective actions planned at this time but will trend for future actions if required.

• 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: 13369412
• Report Number: 3012307300-2022-01957
• Device Sequence Number: 4034064
• 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): 05/04/2023

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: LR419
• 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: 05/03/2023
• 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