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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE
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MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE Back to Search Results
Model Number 70104.4054
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Patient Involvement (2645)
Event Date 05/29/2015
Event Type  malfunction  
Event Description
Description from the customer: "no water flow at cardioplegia side of the hcu40." the malfunction was detected during priming/setup.No pt was involved.(b)(4).(b)(6).
 
Manufacturer Narrative
A maquet field service technician investigated the unit and found the problem with the electrical actuator.The technician replaced the electrical actuator for patient and cardioplegia circuit.The unit was tested to factory specifications.All tests were performed successfully.A supplemental medwatch will be submitted as soon as additional info becomes available.
 
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Brand Name
MAQUET HCU40 DEVICE
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
restatt
GM 
Manufacturer Contact
michael campbell
kehler strasse 31
restatt 76437
GM   76437
2229321132
MDR Report Key4874008
MDR Text Key6062981
Report Number8010762-2015-00758
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K130300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/29/2015
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 Number70104.4054
Device Catalogue Number70104.4054
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/29/2015
Initial Date FDA Received06/25/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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