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

Model Number	9200
Medical Device Problem Codes	Defective Alarm (1014); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that if patient goes into a fib, the device will not register or alarm.No report of patient involvement.
Additional Manufacturer Narrative
H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One product was received.Visual inspection noted the ?tamper? sticker was intact and no impact or corrosion damage was present.Functional testing involved an electrocardiogram (ecg) simulator test.Could not duplicate the issue.Received electrocardiogram (ecg) readings via the simulator and monitor alarms when the readings violate the alarm limits.Electrocardiogram (ecg) function is operating within factory specifications.A device history record (dhr) review was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.Replaced the electrocardiogram (ecg) cable as a preventative measure.

• Brand Name: BCI MULTIPARAMETER MONITOR BCI ADVISOR
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16780680
• Report Number: 3012307300-2023-04343
• Device Sequence Number: 20545425
• Product Code: CCK
• UDI-Device Identifier: 10610586037344
• UDI-Public: 10610586037344
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K030407
• 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,Followup
• Report Date (Section B): 06/02/2023

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
• Operator of Device: Health Professional
• Device Model Number: 9200
• Device Catalogue Number: 920654230A
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown