MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC BCI CAPNOGRAPHY MONITOR CAPNOCHECK PLUS - 9004; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	9004002
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that capnography monitor gave questionable carbon dioxide readings.No patient injury or complications were reported in relation to this event.

• Brand Name: BCI CAPNOGRAPHY MONITOR CAPNOCHECK PLUS - 9004
• 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: 8622395
• Report Number: 3012307300-2019-36749
• Device Sequence Number: 14038505
• Product Code: CCK
• UDI-Device Identifier: 10610586036835
• UDI-Public: 10610586036835
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 106105860368
• 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): 05/18/2019

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 Model Number: 9004002
• Device Catalogue Number: 9004002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1