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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 701028718
Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2016
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. The technician confirmed the problem with the error messages due to a missing 230v ac supply and found a 4 amp filter which was defective. The 4 amp filter was replaced and functional tests were performed. The technician verified and calibrated the unit to factory specification. All tests were performed successfully. A supplemental medwatch will be submitted if additional informations becomes available.
 
Event Description
It was reported that the hcu30 did not produce enough ice and displayed the error messages "30082, "3064", "1008" and "1064" which indicates a defective connection of the 230 v cables. (b)(4).
 
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Brand NameMAQUET HCU30 DEVICE
Type of DeviceCONTROLLER, 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 Key5799564
MDR Text Key50526460
Report Number8010762-2016-00457
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
PMA/PMN Number
K031544
Number of Events Reported1
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 06/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number701028718
Device Catalogue Number701028718
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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