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	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional 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 by being powered on; the reported customer complaint was confirmed.Further visual inspection of the device found it to be damaged due to impact.The lcd and connector were both replaced, resulting in a clear lcd with all segments present.The problem source has been determined to be user interface.This investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.
Event or Problem Description
Information was received that the screen of a smiths medical capnocheck monitor is blank.No adverse effects 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: 8996559
• Report Number: 3012307300-2019-04896
• Device Sequence Number: 16860706
• Product Code: CCK
• UDI-Device Identifier: 10610586036736
• UDI-Public: 10610586036736
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/10/2019

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: 04/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1