MAUDE Adverse Event Report: CEODEUX S.A. INTELLIOX PLUS; GAS CYLINDER REGULATOR

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 07/17/2022

Event Type  Death  

Event Description

Customer alleges that cylinder gauge may have malfunctioned.

• Brand Name: INTELLIOX PLUS
• Type of Device: GAS CYLINDER REGULATOR
• Manufacturer (Section D): CEODEUX S.A.; 24 rue de diekirch; lintgen, lu L-744 0; LU L-7440
• Manufacturer (Section G): CEODEUX S.A.; 24 rue de diekirch; lintgen, lu L-744 0; LU L-7440
• Manufacturer Contact: ron weber ; 259 n radnor chester road; radnor, PA 19087
• MDR Report Key: 15089015
• MDR Text Key: 296464153
• Report Number: 3003764448-2022-00001
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2022
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death