MAUDE Adverse Event Report: NULL BCI; BREATHING-CIRCUIT

Model Number 920654235

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that a smiths medical monitor is not working.No adverse patient effects were reported.

Manufacturer Narrative

Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The failure resulted from malfunctioning co2 board and communication cables unable to properly communicate with the main board.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.

Manufacturer Narrative

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: 3012307300-2021-10315.The report was submitted in error.

• Brand Name: BCI
• Type of Device: BREATHING-CIRCUIT
• Manufacturer (Section G): NULL
• MDR Report Key: 12704677
• MDR Text Key: 278581097
• Report Number: 3012307300-2021-10315
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• 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

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 920654235
• Device Catalogue Number: 920654235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1