MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 70103.4371

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation still in progress a supplemental medwatch will be submitted as soon as additional information becomes available.

Event Description

Biomed contacted tech support for scheduled service on hcu30.The biomed stated that the compressor shuts itself off." additional information: there were no patient involved (b)(4).

Manufacturer Narrative

(b)(4).A maquet field service technician investigated the device.The reported issue was confirmed.A defective current probe was replaced.Functionality and safety checks were performed per the service manual.All tests were executed successfully.

Event Description

(b)(4).(b)(6).

• Brand Name: MAQUET HCU40 DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5302426
• MDR Text Key: 34356949
• Report Number: 8010762-2015-01252
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70103.4371
• Device Catalogue Number: MCP00704629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1