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 did not hold calibration after 30 seconds powered off.No adverse effects were reported.

Manufacturer Narrative

One capnograph was returned for evaluation.Visual inspection of the device found it to be in good physical condition.Device underwent functional testing, confirming the reported complaint.The monitor was calibrated and tested within specification.Then the battery was removed for 30 seconds and the monitor would read co2 around 30 mmhg using 10% cal gas which is out of the spec of 73 +/-3 mmhg.The co2 bench was replaced and the monitor was recalibrated.The battery was then removed several times for over 30 seconds and the monitor held calibration and read accurately.The issue was caused by a faulty co2 bench, however the problem source was not determined.This investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

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: 8192048
• MDR Text Key: 131309621
• Report Number: 3012307300-2018-08943
• 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