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

Model Number 8400D

Device Problems Material Fragmentation (1261); Failure to Calibrate (2440)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: one bci monitor was received for investigation with a purple boot in good condition.The device history record review was completed.Upon functional testing, it was found that the customer had dropped the monitor and broke the elbow off the valve assembly, confirming the customer's reported problem.The broken co2 valve is consistent with unit being severely impacted from a drop.The protective boot around the housing acts as shock absorber preventing damage to the housing.However, centrifugal forces in the time of impact affects internal components, which usually results in component damage.Based on the investigation evidence, the root cause was determined to be user interface.

Event Description

Information was received that a smiths medical bci capnocheck ii capnograph/digital oximeter "will not calibrate" and had "broken pieces inside".No adverse effects were reported.

• Brand Name: BCI CAPNOCHECK II CAPNOGRAPH/DIGITAL 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: 8294001
• MDR Text Key: 134640943
• Report Number: 3012307300-2019-00480
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036736
• UDI-Public: 10610586036736
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991086
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8400D
• Device Catalogue Number: 8400D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1