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

Model Number	8400D
Medical Device Problem Codes	Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: one bci monitor device was received for investigation with a cracked lens and a purple boot.The monitor was powered on and it was found that every other line was missing on the display.All leads on u10 were reflowed due to the monitor suffering severe impact, which caused a leg on the display driver to come loose.Based on the investigation and testing, the complaint was confirmed.It was noted due to the lead reflow, the monitor is now powered up and all segments are present.Conclusively, the broken display controller solder joints failure was noted to be a result of impact sustained by the monitor during use and handling.It was also noted that the operation manual informs the user in chapter 1 & 3 in the warning section with the following information: "any monitor that has been dropped or damaged, should be inspected by qualified service personnel, prior to use, to insure proper operation.".
Event or Problem Description
Information was received that a smiths medical bci capnocheck ii capnograph monitor had a broken screen.The issue was found during the device planned maintenance.No adverse effects were reported.

• Brand Name: BCI CAPNOCHECK II CAPNOGRAPH MONITOR
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9288465
• Report Number: 3012307300-2019-05947
• Device Sequence Number: 14044219
• Product Code: CCK
• UDI-Device Identifier: 10610586036736
• UDI-Public: 10610586036736
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K991086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8400D
• Device Catalogue Number: 8400D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1