MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG MAQUET HEATER COOLER UNIT HCU 30; CONTROLLER, TEMPERATURE, CPB

Model Number 70103.4653

Device Problem Smoking (1585)

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

Event Date 10/05/2011

Event Type  Injury  

Event Description

On (b)(6) 2011 at the (b)(6) hospital in (b)(6).It was reported that there was a burning smell coming from the heater cooler unit 30 (hcu 30) serial number (b)(4).The incident occurred during use.Reference: complaint (b)(4).

Manufacturer Narrative

(b)(4).Per the non-conformity report, the power supply board was damaged and was replaced.Reference: complaint (b)(4).

• Brand Name: MAQUET HEATER COOLER UNIT HCU 30
• Type of Device: CONTROLLER, TEMPERATURE, CPB
• Manufacturer (Section D): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 76437 ; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 76437 ; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4280241
• MDR Text Key: 5010805
• Report Number: 8010762-2014-01212
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70103.4653
• Device Catalogue Number: MCP00705501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/09/2011
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2011
• Date Manufacturer Received: 12/09/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention