MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOHELP

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) provides product 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 CARDIOHELP
• Type of Device: CARDIOHELP
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 harbour pond dr; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3883039
• MDR Text Key: 15818005
• Report Number: 8010762-2014-00215
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 05/03/2014
• Initial Date FDA Received: 05/29/2014
• 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