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

Catalog Number	8400D
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One capnography monitor was returned for evaluation.Visual inspection of the device found it to be in good physical condition.Device underwent functional testing by performing the flow rate test; the results found it to have no flow.Upon further internal inspection, it was noted to have a broken valve assembly connector/hose which caused the failure.The problem source of the broken connector was determined to be from impact.Additionally, the speaker was found to be loose and will be melted back into position.The restrictor was replaced and the flow rate increased back to within specification.The problem source was determined to be user interface.
Event or Problem Description
Information was received that a smiths medical bci capnography monitor capnocheck ii had a co2 error message and system failure.No adverse effects were reported.

• Brand Name: SMITHS MEDICAL BCI CAPNOGRAPHY MONITOR CAPNOCHECK II
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8965930
• Report Number: 3012307300-2019-04729
• Device Sequence Number: 16654617
• Product Code: CCK
• UDI-Device Identifier: 10610586036736
• UDI-Public: 10610586036736
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K991086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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
• Operator of Device: No Information
• Device Catalogue Number: 8400D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1