MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLS SET ADVANCED 7.0; OXYGENATOR

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A supplemental medwatch will be submitted if additional info becomes available.Ref.(b)(4).

Event Description

(b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• Type of Device: OXYGENATOR
• 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 barbour pond dr.; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3723724
• MDR Text Key: 22216476
• Report Number: 8010762-2014-00161
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K102532
• 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: 02/24/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1