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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 701028718 - HCU 30
Device Problem Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/06/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that the device displayed the error message "3004-2". The alarm disappeared after the machine was restarted. The field service technician was on site and investigated the unit in question. The technician troubleshooted the device and checked the parts (actuator, 3-way valve,circulation hose and pt1000 temperature sensor) that may be responsible for the reported error message. No abnormalities were found and the technician could not reproduce the error. Thus the failure could not be confirmed. Since no parts were replaced and the device is already back in use, no further investigation could be performed. Therefore no most probable root cause could be determined. The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
 
Event Description
A "3004-2" error occurred during the operation. The field service technician (fst) checked the machine and could not reproduce the error. The actuator, 3 -way valve, circulation hose and the pt 1000 temperature sensor were also checked. No abnormalities were found. According to the fst it was a transient error. Complaint number: (b)(4).
 
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Brand NameHEATER COOLER UNIT
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
NURSEL BOELENS
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
GM 76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
4972229321
MDR Report Key9096586
MDR Text Key199893017
Report Number8010762-2019-00293
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K031544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number701028718 - HCU 30
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 Received09/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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