MAUDE Adverse Event Report: NULL BCI CAPNOGRAPHY BOARD APC ADV PNEUMATICS; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 1410AG

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

It was reported that a smiths medical 1410ag board shows a waveform like spike noise on the co2 signal after power on.

Manufacturer Narrative

Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.However, it was determined that the agent bench failed the frequency difference test that was unrelated to the original complaint.Dhr review was done, no issues related to the original complaint were found.

Manufacturer Narrative

Other, other text: 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: 3012307300-2021-11165.The report was submitted in error.

• Brand Name: BCI CAPNOGRAPHY BOARD APC ADV PNEUMATICS
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section G): NULL
• MDR Report Key: 12808041
• MDR Text Key: 280761155
• Report Number: 3012307300-2021-11165
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1410AG
• Device Catalogue Number: 1410AG
• Device Lot Number: 4103608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1