MAUDE Adverse Event Report: SMITHS MEDICAL, INC. CAPNOCHECK PLUS MONITOR; ANALYZER, CARBON DIOXIDE

Catalog Number V90040

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that when new battery placed into unit, it started to smoke.Unsure whether the smoke was coming from the battery or monitor.No adverse health outcome resulted.

Manufacturer Narrative

The suspect co2 monitor was returned for product investigation.The device housing was observed opened, the wires and tubing were disassembled, the tamper sticker was broken, and a resistor on the main board was burned out.During functional testing, the reported product problem was duplicated.The battery cable was plugged into an outlet, and the device began smoking from the burned out resistor.Inspection found the battery cable wires improperly connected to the device.Once the battery cable and mainboard were replaced, the device operated as intended.The reporter indicated that the device began smoking after they had performed maintenance on the device and changed the battery.Therefore, the root cause for the smoking device is due to a shorted resistor that resulted from an improperly installed battery.

• Brand Name: CAPNOCHECK PLUS MONITOR
• Type of Device: ANALYZER, CARBON DIOXIDE
• Manufacturer (Section D): SMITHS MEDICAL, INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5050384
• MDR Text Key: 24891672
• Report Number: 2183502-2015-00635
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V90040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2011
• 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