MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 70104.8012# CARDIOHELP-I

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).The patient expired when the cardiohelp-i therapy was withdrawn.Maquet cardiopulmonary (b)(4) has requested additional more detailed information about the incident, but has not received a response.A supplemental medwatch will be submitted when additional information becomes available.(b)(4).

• Brand Name: 70104.8012# CARDIOHELP-I
• Type of Device: CARDIOHELP-I
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4752327
• MDR Text Key: 5885386
• Report Number: 8010762-2015-00390
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 04/06/2015
• 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