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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOPULMONARY AG; HL 20 CONSOLE BASE
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MAQUET CARDIOPULMONARY AG MAQUET CARDIOPULMONARY AG; HL 20 CONSOLE BASE Back to Search Results
Catalog Number 70104.3306
Device Problem Pumping Stopped (1503)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2014
Event Type  malfunction  
Event Description
It was reported that the unit completely shut down with the exception of the roller pumps.The control unit and all interventions would not turn back on.Case was completed using the hl-20.(b)(4).
 
Manufacturer Narrative
A maquet field service technician will investigate this event.A supplemental medwatch will be submitted when additional information becomes available.
 
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Brand Name
MAQUET CARDIOPULMONARY AG
Type of Device
HL 20 CONSOLE BASE
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
Manufacturer Contact
michael campbell
kehler strabe 31
rastatt 76437
GM   76437
2229321132
MDR Report Key4536031
MDR Text Key15896444
Report Number8010762-2015-00096
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/22/2014
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 Catalogue Number70104.3306
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/23/2014
Initial Date FDA Received02/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2013
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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