MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; HCU30-100-120V

Device Problems Misconnection (1399); Use of Device Problem (1670); Misassembly by Users (3133)

Patient Problem Ventricular Fibrillation (2130)

Event Type  Injury  

Event Description

Please refer importer report # (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 if additional info becomes available.

• Brand Name: MAQUET HCU30 DEVICE
• Type of Device: HCU30-100-120V
• 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 dr.; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3599100
• MDR Text Key: 4166451
• Report Number: 8010762-2014-00013
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 01/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 12/10/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1