MAUDE Adverse Event Report: MEDSOURCE INTERNATIONAL LLC ADULT NASAL/ORAL DUALCO2 SAMPLING CANNULA W/O2 DELIVERY; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 00840155408944

Device Problem Unable to Obtain Readings (1516)

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

Event Date 01/23/2023

Event Type  malfunction  

Event Description

The nasal capnography device did not read.The lot number has been reported to the manufacturer and all devices with that lot number have been pulled from service.

• Brand Name: ADULT NASAL/ORAL DUALCO2 SAMPLING CANNULA W/O2 DELIVERY
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): MEDSOURCE INTERNATIONAL LLC
• MDR Report Key: 16411520
• MDR Text Key: 310094565
• Report Number: MW5115072
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00840155408944
• Device Lot Number: 2001003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White