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

Catalog Number 8400

Device Problems Failure to Cycle (1142); Display or Visual Feedback Problem (1184); Failure to Read Input Signal (1581)

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 cracked display something loose inside the device most likely due to impact.The monitor came in for "c02 source failure code, the bench cause error, lens found crack, keypad due to lens, restrictor add to increase flow and labels missing.The customer's stated problem was verified.Flow meter test was performed and there was no flow when testing.The device was opened and there were 2 tubes that were loose and need to be reconnected.The damaged lcd from within the device is consistent with unit being severely impacted from drop.The protective boot around the housing acts as shock absorber preventing damage to the housing; however direct impact to the lcd display usually results in cracks and ink leak.

Event Description

Information was received that a smiths medical bci capnocheck ii capnograph was "not registering any breaths".No adverse patient effects were reported.

• Brand Name: BCI CAPNOCHECK II HAND-HELD CAPNOGRAPH/OXIMETER
• 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: 8576160
• MDR Text Key: 143942255
• Report Number: 3012307300-2019-02411
• Device Sequence Number: 1
• Product Code: CCK
• 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: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2002
• 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