MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL BCI CAPNOGRAPHY MONITOR CAPNOCHECK II - 8400; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Catalog Number 8401

Device Problem Gas Output Problem (1266)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

One capnograph was received for evaluation.Visual inspection of the device found it to be in poor physical condition with a crack inside the port-causing leakage.Device underwent flow rate test, and c02 functional tests.The reported customer complaint has not been verified.The monitor underwent a series of flow rate tests.As a result, it had a low rate of 61 ml/min; specification of the device is 120 +/- 20 ml/min.Additionally, when the test filter was moved around, the flow rate would change.Upon further visual inspection of the port on the back of the housing, there was damage inside the port causing a leak.A new test housing was used, and the monitor then tested within specification.The problem source has been determined to be user interface, as damage is a result of impact to the monitor.

Event Description

Information was received that a smiths medical capnocheck has high co2, unstable.No adverse effects reported.

• Brand Name: SMITHS MEDICAL BCI CAPNOGRAPHY MONITOR CAPNOCHECK II - 8400
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north; suite 100; oakdale MN 55128
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9371229
• MDR Text Key: 176315752
• Report Number: 3012307300-2019-06792
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• 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: 08/06/2019
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2012
• 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