MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; HCU 30 BASE UNIT 200-240 V

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).A maquet field service technician confirmed the defective hose assembly and replaced the male connector.System was satisfactorily tested to factory specifications and returned to service.(b)(4).A supplemental medwatch will be submitted if additional information becomes available.

• Brand Name: MAQUET HCU30 DEVICE
• Type of Device: HCU 30 BASE UNIT 200-240 V
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; kehler 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4559076
• MDR Text Key: 5459156
• Report Number: 8010762-2015-00221
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1