MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI CAPNOCHECK II CAPNOGRAPH; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE PRODUCT CODE: CCK

Catalog Number 8401

Device Problems Break (1069); Failure to Cycle (1142)

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

Event Type  malfunction  

Manufacturer Narrative

The reported bci capnocheck ii capnograph affected was received by smiths medical with a crack on the bottom of lens.The customer's stated problem was verified.Flow rate / leak test was attempted the device did not function when testing was performed.The device was opened it was revealed that the elbow joint to the valve was broken.The valve will be replaced and the cracked display will be replaced.Investigation determined that the failure is a result of impact sustained by the monitor during use and handling.Trends have been identified related to this type of failure and further analysis identified the design to be a contributing factor as the co2 pump has no fastening system leaving it to dislocate on impact and knock other components internally.

Event Description

Information was received that a smiths medical bci capnocheck ii capnograph will not pass high pressure & co2 error, display is cracked.No adverse patient effects were reported.

• Brand Name: BCI CAPNOCHECK II CAPNOGRAPH
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE PRODUCT CODE: CCK
• 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: 8567596
• MDR Text Key: 143684521
• Report Number: 3012307300-2019-02269
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: 10610586036781
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Date Manufacturer Received: 03/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2012
• 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