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); Electronic Property Issue (2928)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when plugging into the back of a bci® capnocheck® sleep capnograph/oximeter, electrical currents were seen coming out of it.Reporter stated the machine would not turn on and it was hot while running.No injury was reported.
Additional Manufacturer Narrative
Additional information received stating the customer saw a large spark coming from where the plug attaches to the machine.The event date is unknown to the customer.One sleep capnograph was returned for evaluation.Visual inspection of the device has found it to be in good physical condition.Ac power supply was connected to the device as functional testing.The reported customer complaint was verified, as the monitor was unable to power up after charging battery for four hours.Electrical discharge (sparking) occurs when the 1616xx power supply is connected to a 6004 mini-torr plus®, 9004 capnocheck sleep® or capnocheck plus® monitor after it has been plugged into an electrical outlet.Customer's problem occurred because the ifu instructions were not followed.The ifu states, "please connect the ac charger to the ac power connector of the monitor first and the ac charger to the wall outlet second." the battery voltage was measured at 2.5v , which is below specification of 6v.The battery was replaced with a brand new battery and the monitor powered up properly.Monitor was charged two hours to full capacity, and then lasted four hours on full charge on continuous run without the case becoming hot.The problem source is related to the design of the product.

• 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: 7294507
• Report Number: 3012307300-2018-00352
• Device Sequence Number: 1354882
• Product Code: CCK
• UDI-Device Identifier: 10610586036873
• UDI-Public: 10610586036873
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K970209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 9004051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 02/24/2018
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1