MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CUSTOMER REPORTED THAT "UNIT SHUT OFF DURING CASE" NO PATIENT HARM WAS REPORTED.; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCP00704629

Device Problem Loss of Power (1475)

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

Event Date 06/06/2016

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 follow-up medwatch will be submitted if additional information becomes available.

Event Description

Customer reported that "unit shut off during case" no patient harm was reported.(b)(4).

Manufacturer Narrative

A maquet field safety technician was on site and investigated the unit in question.The technician found that the ac connection between the 20 amp breaker/switch and the filter assembly was charred at the connection to the 20 amp breaker.The technician replaced the breaker and associated the wiring.The unit was tested for factory specifications and returned to service.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

(b)(4).

• Brand Name: CUSTOMER REPORTED THAT "UNIT SHUT OFF DURING CASE" NO PATIENT HARM WAS REPORTED.
• 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: 5762836
• MDR Text Key: 49280148
• Report Number: 8010762-2016-00419
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00704629
• Device Catalogue Number: 70103.4371
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• 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