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

Model Number	9004051
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical bci capnocheck sleep oximeter "will not hold 1volt calibration".No adverse effects were reported.
Additional Manufacturer Narrative
Corrected information: the file was inadvertently marked reportable.The event reported under mfr was determined to be not reportable and no further reports will be filed using this file number.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.

• Brand Name: BCI CAPNOCHECK SLEEP OXIMETER
• 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: 8557474
• Report Number: 3012307300-2019-02180
• Device Sequence Number: 16758707
• Product Code: CCK
• UDI-Device Identifier: 10610586036873
• UDI-Public: 10610586036873
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K970209
• 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,Followup
• Report Date (Section B): 05/23/2019

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: 9004051
• Device Catalogue Number: 9004051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1