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

Catalog Number 9004051

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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.

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 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
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 3350 granada avenue; oakdale MN 55128
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6315691
• MDR Text Key: 67223002
• Report Number: 3012307300-2017-00341
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036873
• UDI-Public: 10610586036873
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 9004051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1