MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 701034371

Device Problems Failure to Power Up (1476); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A maquet field service technician was on site and investigated the unit in question.The technician troubleshooted the unit and determined that the fuse on the power supply was open causing the compressor not to turn on.The technician replaced the defective fuse with a non inventory part.The unit passed all functional and safety tests per factory specifications.The unit was returned to the customer and cleared for clinical use.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

According to the customer: the customer stated that the hcu30 would not make ice and the compressor won't turn on.Additional information: there were no patient involved the incident occurred during sterilization of the device.(b)(4).

• Brand Name: MAQUET HCU30 DEVICE
• 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: 5900485
• MDR Text Key: 53976482
• Report Number: 8010762-2016-00543
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701034371
• Device Catalogue Number: MCP00704629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• 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