MAUDE Adverse Event Report: ST PAUL BCI; ESOPHAGEAL STETHOSCOPE TEMPERATURE SENSOR

Model Number	8400
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device reading was inaccurate.No patient injury reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The monitor was powered up and the monitor kept performing an autozero, the monitor had no flowrate.The monitor was opened and the all tubing were full of fluid ingression which went all the way to the bench.The root cause of the reported issue was found to be improper handling of device that allowed water or fluid to enter the monitor.It was noted flowrate test, visual, occlusion test, factory calibration.The monitor came in for ?reading inaccurate? the customers comments were verified.The monitor was powered up and the monitor kept performing an autozero, the monitor had no flowrate.The monitor was opened and the all tubing were full of fluid ingression which went all the way to the bench.The bench, naphion tubing ang a tubing kit were all replaced for the monitor to have a flowrate of 128 ml/min (spec is 120+/-20 ml/min) and passed the factory calibration.Fluid ingression in the bench.User interface.Replaced the bench, tubing lit and naphion tubing.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BCI
• Common Device Name: ESOPHAGEAL STETHOSCOPE TEMPERATURE SENSOR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15422606
• Report Number: 3012307300-2022-19200
• Device Sequence Number: 6554302
• Product Code: CCK
• UDI-Device Identifier: 10610586036354
• UDI-Public: 10610586036354
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K991086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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: 8400
• Device Catalogue Number: 8400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 09/14/2022
• 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