MAUDE Adverse Event Report: ST PAUL BCI CAPNOCHECK PLUS; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 9004000

Device Problems Inappropriate Waveform (2536); Naturally Worn (2988); Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

Operator of device is unknown; no additional information was received.The device was returned for evaluation.It was received intact with no damage.Functional tests -factory calibration, hi/lo calibration, and flowrate test- were performed.The reported problem of stop and starts was not verified but the customer did not send in their water trap.For the evaluation of the 1616 ac cord, it had 24 volts but the end of it was wrapped with tape.The wave form problem was verified, the readings were out of specification.The bench was replaced, factory calibration and a hi/lo calibration were performed; thereafter, the readings were within specifications.The reported problem was caused by a defective bench; but root cause could not be determined.This was the first time this service was put in for service after six years in the field and the failure resulted from malfunctioning co2 bench.The device history record (dh) review was not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.The device was manufactured in 2013.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the device was not giving the proper waveform, pump starts/stops, and the ac adaptor is worn.No patient injury was reported.

• Brand Name: BCI CAPNOCHECK PLUS
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• 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: 15422562
• MDR Text Key: 306066984
• Report Number: 3012307300-2022-19198
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036811
• UDI-Public: 10610586036811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Model Number: 9004000
• Device Catalogue Number: 9004000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 09/14/2022
• 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