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.A review of the dhr was also completed.During functional testing, it was found that the monitor was returned with a calibration error.The device was recalibrated and tested and readings were found to be continuing to "go up and down".Therefore, the bench was replaced and the readings became accurate and steady.Based on the investigation evidence, the complaint allegation was confirmed.However, the cause of the defective co2 bench was unknown.Possible problem sources noted were that the bench was effected by impact or the bench had worn over time in operation.

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: 8192046
• MDR Text Key: 131309612
• Report Number: 3012307300-2018-08940
• 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

• 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
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 03/20/2019; 04/25/2019
• Supplement Dates FDA Received: 04/18/2019; 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1