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

Catalog Number 9004050

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

According to user facility, when battery attached to the main board, the listed device was observed to start smoking.No adverse effects to the patient or user were reported.

Manufacturer Narrative

The capnograph device was received for evaluation.Visual inspection observed the main board to be burnt around the battery connector and the keyed side of the board's battery connector was blown apart and melted.The female connector on the battery revealed burn marks on the side that was keyed indicating the connector was plugged in incorrectly to the board which reversed the polarity causing the circuity on the board to blow.The battery was found to be functional, however when connected to the main board correctly, the capnograph would not power on.The capnograph would power on when a test power supply was plugged into it.The battery circuitry on the main board was damaged and the main board replaced.The battery is internal, requiring the capnograph to be opened up and board removed to replace the battery.The end user connected the plug incorrectly resulting in the reported issue.

• Brand Name: CAPNOCHECK SLEEP CAPNOGRAPH/OXIMETER
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL, INC.; st. paul MN
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4892632
• MDR Text Key: 18790276
• Report Number: 2183502-2015-00483
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9004050
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1