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

Catalog Number 8401

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

One used device was received for investigation.A visual inspection found the device to be in good physical condition.The investigation was able to confirm that half the display was not showing.This type of missing pixels is typically due to an lcd internal crack that was consistence with damage from impact.The root cause was determined to be improper user interface.

Event Description

It was reported that half of the display of the capnography monitor was not showing.No injury was reported.

• Brand Name: BCI® CAPNOCHECK® II HAND-HELD CAPNOGRAPH OXIMETER
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7651988
• MDR Text Key: 112844965
• Report Number: 3012307300-2018-02388
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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: 03/26/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2013
• 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