MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI CAPNOCHECK II CAPNOGRAPH MONITOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 8401

Device Problem Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2018

Event Type  malfunction  

Event Description

Information was received that a smiths medical bci capnocheck ii capnograph monitor is unable to hold calibration when the battery is removed.No adverse effects were reported.

Manufacturer Narrative

Device evaluation: one bci monitor was received for investigation with a purple boot and its chargeable battery.The monitor was powered on and 10% cal gas was applied and the reading was 33 mmhg.It was noted the barometric pressure of 745 mmhg it should read 75.0 mmhg +/-3; so it was out of specification.The investigator also performed a lo cal, applied gas again, and the device read 70 mmhg, which was still is out of specification.The device was performing in specification (spec) during a hi/lo calibration.In addition, the battery was removed several times and the 10% gas was applied and all readings were found to be accurate and steady.Only smiths-medical recommended 10%cal gas are to be used when calibrating the 8400 capnographs.Based on the investigation evidence, the complaint allegation was not confirmed.However, the investigation did find that the co2 bench calibration data was out of range.It is unknown whether or not the recommended routine calibration were followed by the user or whether the defective co2 valve was acting out when calibration is performed by the user.

Manufacturer Narrative

Additional information: information was received that there was no patient involvement and no harm when the device issue occurred.Additionally, it was noted the event likely happened sometime in 2018 (month unknown) due to the customer stating "not sure of date but was within 2 weeks before we sent in the rma request" regarding the incident date.

• Brand Name: BCI CAPNOCHECK II CAPNOGRAPH MONITOR
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8192049
• MDR Text Key: 131309994
• Report Number: 3012307300-2018-08939
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: 10610586036781
• Combination Product (y/n): N
• PMA/PMN Number: K991086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8401
• Device Catalogue Number: 8401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1