MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CAPNOGRAPHY MONITOR CAPNOCHECK PLUS - 9004; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation results: one capnography monitor capnocheck plus (9004) was returned or investigation in a damaged state.All the cases were cracked and the monitor failed to turn on.The battery was replaced and calibration was performed on the monitor.The following parts were also replaced due to customer damage: top case, bottom case, front bezel, keypads, barrel, as well as all the labels.A hi/lo calibration was also performed.The device passed all functional tests after these changes were made.
Event or Problem Description
It was reported that the capnography monitor capnocheck plus (9004) exhibited physical damage and required calibration.No patient death or serious injury was reported in relation to this event.

• Brand Name: CAPNOGRAPHY MONITOR CAPNOCHECK PLUS - 9004
• 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: 8575587
• Report Number: 3012307300-2019-02416
• Device Sequence Number: 245079
• Product Code: CCK
• UDI-Device Identifier: 10610586036828
• UDI-Public: 10610586036828
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 106105860368
• 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): 05/02/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1