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

Model Number WW3311E

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported that the cables were found to have suspected fractures within the plug/strain relief at the sensor end of the cable which caused intermittent signal transmission when gently flexed.No patient injury was reported.

Event Description

Additional information received via email on 2 september 2022: event dates are unknown.Intermittent operation was noted over several weeks use; no patient or clinician injury associated.

Manufacturer Narrative

Other text: a customer response was attached to the complaint.(updated b5).

• Brand Name: BCI CAPNOCHECK PLUS
• 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: 15104598
• MDR Text Key: 304473601
• Report Number: 3012307300-2022-14204
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 15019517058253
• UDI-Public: 15019517058253
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WW3311E
• Device Catalogue Number: 3311
• Device Lot Number: 021525-1-6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1