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

Model Number 9004050

Device Problems Sparking (2595); Calibration Problem (2890)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received that a smiths medical bci capnocheck sleep capnograph monitor sparked when the device was plugged in.It was also noted that the monitor could not calibrate.No adverse effects were reported.

• Brand Name: BCI CAPNOCHECK SLEEP CAPNOGRAPH MONITOR
• 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.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8911773
• MDR Text Key: 154924574
• Report Number: 3012307300-2019-04257
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036866
• UDI-Public: 10610586036866
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2019

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
• Device Operator: No Information
• Device Model Number: 9004050
• Device Catalogue Number: 9004050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1