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

Model Number MX960

Device Problem Inappropriate Waveform (2536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2021

Event Type  malfunction  

Event Description

It was reported that no waveforms were showing.No additional information.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history review.Six units were returned for evaluation.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: sn (b)(6) : unit found to be missing plated pin insert connecting to an output pin.Sn (b)(6) : unit found to be missing plated pin insert connecting to an input pin.Sn (b)(6) : unit found to be missing plated pin insert connecting to an input pin.Sn (b)(6) : unit found to be missing plated pin insert connecting to an input pin.Sn (b)(6) : unit found to be missing plated pin insert connecting to an output pin along with missing plated insert pin for drain.Sn ml450: unit found to be missing output pin.Unable to functional test.During functional testing, five of the returned units were tested per internal test specification and 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 complaint database was reviewed and there 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.Root cause is unknown.No corrective actions planned at this time but will trend for future actions if required.

• Brand Name: MEDEX LOGICAL TRANSDUCERS
• Type of Device: 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: 13367605
• MDR Text Key: 286746395
• Report Number: 3012307300-2022-01930
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 10351688502988
• UDI-Public: 10351688502988
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX960
• Device Catalogue Number: MX960
• Device Lot Number: ML450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1