MAUDE Adverse Event Report: ST PAUL BCI; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 8400

Device Problems Display or Visual Feedback Problem (1184); Unable to Obtain Readings (1516); Key or Button Unresponsive/not Working (4063)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2021

Event Type  malfunction  

Event Description

It was reported that a smiths medical capnocheck has a defective lcd and keypad.No adverse patient effects were reported.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection did found the tamper seal was removed.The reported complaint was confirmed and verified after power on the returned 8400 monitor and there was a missing segment on the lcd.There was also a crack found on the lens at the bottom center.Opened the monitor, found the c02 pump shifted out of position.Due to all the damage found on the device, this was determined by impact to the monitor.The c02 pump and speaker connection on the main board was swapped.The tamper sticker was removed.The on/off switch was intermittently working.The lcd, lens and keypad were replaced.The root cause was established to be determined by the user interface and interaction with the device.The missing pixel lines and cracked lcd lens are consistent with unit being physically impacted.The protective boot around the housing acts as shock absorber preventing damage to the housing, however pressure to the display and centrifugal forces in the time of impact affects pixels alignment in the lcd grid are known for resulting in pixels damage.Operation manual warned at its chapter 1 and 3 in the warning section as follow -any monitor that has been dropped or damaged, should be inspected by qualified service personnel, prior to use, to insure proper operation.- first time in for service after 5 years in the field and the failure resulted from a combination of physical impact to the monitor and malfunctioning keypad.The dhr review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4)., as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-11211.

• Brand Name: BCI
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12808325
• MDR Text Key: 280769094
• Report Number: 3012307300-2021-11211
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036354
• UDI-Public: 10610586036354
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2023

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
• Device Operator: Health Professional
• Device Model Number: 8400
• Device Catalogue Number: 8400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/13/2021
• Supplement Dates Manufacturer Received: 12/21/2021; 05/02/2023
• Supplement Dates FDA Received: 01/18/2022; 05/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1