MAUDE Adverse Event Report: GETINGE / MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I HEART LUNG SUPPORT SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

There was a non-conformance related to the assessment of leakage current during the manufacture of the affected system.

• Brand Name: CARDIOHELP-I HEART LUNG SUPPORT SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): GETINGE / MAQUET CARDIOPULMONARY GMBH
• MDR Report Key: 18256903
• MDR Text Key: 329716629
• Report Number: MW5148686
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2023
• Patient Sequence Number: 1