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

Model Number 9004050

Device Problems Gas Output Problem (1266); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation : one bci monitor was received for investigation with an adapter and a moisture trap.The device then underwent visual inspection, flow rate testing, and co2 testing.Upon testing, it was found that the sample line snapped off of the device.Based on the evidence and testing, the complaint was confirmed.The investigation determined broken rear tubing resulted from improper handling and twisting of the tubing when removing and connecting the disk filter or from pushing the tubing again other devices during storage or moving.The device operation manual (chapter 2) on intended use and monitor description instructs the customer how to properly connect the rear sample line to the filter and the monitor under filter port: description as follows:" to connect the filter: connect the female end into the male luer on the tubing.Push in and twist the filter until it is firmly seated.Connect the male end to the port on the monitor.Perform a leak test according to the monitor's instructions.".

Event Description

Information was received that a smiths medical bci capnocheck sleep oximeter gas sample line was broken.No adverse effects were reported.

• Brand Name: BCI CAPNOCHECK SLEEP 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.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9377141
• MDR Text Key: 168235929
• Report Number: 3012307300-2019-06652
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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: 07/22/2019
• Date Manufacturer Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2013
• 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