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

Model Number 701028718

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The technician observed the system and troubleshot to power supply.The technician rewired the 20 amp breaker connections and replaced the 20 amp breaker as a precaution.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.A supplemental medwatch will be submitted if new information has been received.

Event Description

It was reported that the hcu 30 shut down during use.The incident occurred during patient treatment and the device was exchanged for another.There were no negative consequences to the patient.(b)(4).

• 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: 6131440
• MDR Text Key: 61401974
• Report Number: 8010762-2016-00692
• 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
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701028718
• Device Catalogue Number: MCP00939001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2005
• 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