• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL BCI CAPNOCHECK II, MODEL 8400 ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST PAUL BCI CAPNOCHECK II, MODEL 8400 ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 8401
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacturing of the device or prior repair of the device. A product sample was received for evaluation. Visual inspection and functional testing were performed. The technician found that the speaker was loose and pump was dislodged. Functional testing could not confirm the complaint. This device not measure saturation of peripheral oxygen (spo2). The technician tested the flow rate and co2 readings. Both the readings were within the specification. The root cause could not be determined as the reported issue and complaint were not confirmed. Operator of device is unknown. No product information has been provided to date. This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
 
Event Description
It was reported that the device was not providing oxygen readings. No patient injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBCI CAPNOCHECK II, MODEL 8400
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15328962
MDR Text Key302939404
Report Number3012307300-2022-17073
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10610586036781
UDI-Public10610586036781
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K991086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number8401
Device Catalogue Number8401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2020
Was the Report Sent to FDA? No
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

-
-