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

Catalog Number	9004051
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.Device evaluation in progress.
Event or Problem Description
It was reported that a bci® capnocheck® sleep capnograph/oximeter was hot and smoking.The device's green power light did not function.No patient injury was reported.
Additional Manufacturer Narrative
One bci® capnocheck® sleep capnograph/oximeter was returned for investigation.Visual inspection of the device revealed that the tamper sticker had been removed and the battery was disconnected from the mainboard inside the device.Additionally, it was noted that the rechargeable battery was not a designated battery that smiths medical installs.During functional testing, the device was powered on with a test power supply and it was noted that the power/charge green indicator light did not power on.The device was opened and examined and it was observed that the heatsink was warmer than usual; however, no smoke was found escaping from the device.Further examination of the device found that the output voltage at the charging section of the main board was elevated which resulted in excessive voltage being delivered to the heatsink.The excess voltage at the heatsink caused the heatsink to overheat.Additionally, the switch output voltage at the regulator was too low to turn the device on with ac power and the battery was not charging.The observed missing tamper sticker and the non-smiths medical designated battery indicated that the device was tampered with by the user; therefore, investigation was unable to determine the root cause of the failed mainboard component.After device repair and recalibration, the device was found to pass all delivery, accuracy and functional tests.
Event or Problem Description
It was further reported that there was no patient or staff involvement when the reported issue occurred.

• Brand Name: BCI® CAPNOCHECK® SLEEP CAPNOGRAPH/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: 6315691
• Report Number: 3012307300-2017-00341
• Device Sequence Number: 733202
• Product Code: CCK
• UDI-Device Identifier: 10610586036873
• UDI-Public: 10610586036873
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K970209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2017

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: Other
• Device Catalogue Number: 9004051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 03/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1