MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; HCU30 SYSTEM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Arrhythmia (1721); Death (1802)

Event Type  Death  

Event Description

Ref imp # (b)(4).

Manufacturer Narrative

(b)(4).Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.A supplemental medwatch will be submitted when additional info becomes available.

• Brand Name: MAQUET HCU30 DEVICE
• Type of Device: HCU30 SYSTEM
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3694650
• MDR Text Key: 4255048
• Report Number: 8010762-2014-00136
• 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: Health Professional,User Facility,Company Representative
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1