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

Model Number 9004051

Device Problems Device Alarm System (1012); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that the capnography monitor gave a co2 sensor alarm.Information pointed to the co2 bench on the transducer having gone bad and needing to be replaced.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Other text: the device was returned for evaluation.The keypad was detached from the front bezel.Functional tests indicated that the co2 bench lost its factory calibration memory data.The root cause is undetermined.Factory calibration was performed to clear the sensor error.(h6c, h6d, h6e).Additional event information received indicating no patient involvement and date of event was received.A manufacturing device history record review was not performed, due to the age of the device.

Event Description

Additional information was received via email on 02-oct-2022.Event date was updated.No patient was involved.

• Brand Name: BEDSIDE CAPNOGRAPHY MONITORS
• 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: 15505129
• MDR Text Key: 306333884
• Report Number: 3012307300-2022-20505
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036873
• UDI-Public: 10610586036873
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9004051
• Device Catalogue Number: 9004051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1