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

Model Number MX960

Device Problems Device Difficult to Program or Calibrate (1496); Failure to Calibrate (2440); Calibration Problem (2890)

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

Event Date 11/08/2019

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 306898840
• Report Number: 3012307300-2022-26260
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 10351688502988
• UDI-Public: 10351688502988
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• 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: KH828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1