MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR; MX960 REUSABLE PRESSURE TRANSDUCER

Model Number	MX960
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Failure to Calibrate (2440); Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Device history report review: the lot number manufactured in june 2018 in a qty (b)(4).No product remaining in inventory of lot for additional investigation.A product sample was received for evaluation.Visual and functional testing were performed.Unit was visually inspected on receipt under 10x magnification with no issues being noted.Unit was functional tested per internal specifications and failed to meet requirement (see attached test results).Unit was additionally tested on monitor for intermittent connection and no test connection was able to be produced.The root cause of the reported issue was found to be the internal connection ribbon cable broke loose at the solder connection on the sensor transducer unit.Under 10x magnification the solder connection appears to have lifted from the sensor connection pad.Reviewed complaint database and no additional failures are listed with this lot number series for this failure mode.No additional investigation and no adverse trends have been identified related to this issue.No corrective actions are planned at this time.The manufacture will regularly analyze complaint data and trends and will take further actions accordingly.
Event or Problem Description
It was reported that the zero point calibration could not be performed.While pressing the zero calibration button on the polygraph, the waveform did not become flat and could not be calibrated.No patient injury was reported.

• Brand Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Common Device Name: MX960 REUSABLE PRESSURE TRANSDUCER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15674488
• Report Number: 3012307300-2022-26260
• Device Sequence Number: 6321046
• Product Code: DRS
• UDI-Device Identifier: 10351688502988
• UDI-Public: 10351688502988
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2022

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: KH828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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