MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HEATER-COOLER UNIT HCU40; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number DECP.HCU40

Device Problems Device Maintenance Issue (1379); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).A maquet field service technician was on site and investigated the unit and confirmed failure.Failure detected and sensor for outlet replaced.Functional tests for hours performed and found ok.Electrical evaluation performed.The defective sensor was requested for a investigation.After the investigation results becomes available a final medwatch report will be submitted.

Event Description

Description from the customer report: "it was reported that during maintenance patient side temperature heats permanently." the incident was discovered during maintenance.No patient involvement.(b)(4).

• Brand Name: MAQUET HEATER-COOLER UNIT HCU40
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5758836
• MDR Text Key: 49235687
• Report Number: 8010762-2016-00415
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DECP.HCU40
• Device Catalogue Number: DECP.HCU40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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