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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL 30 CONSOLE BASE
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MAQUET CARDIOPULMONARY AG HL 30 CONSOLE BASE Back to Search Results
Model Number HL 30
Device Problem Pumping Stopped (1503)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2014
Event Type  Injury  
Event Description
It was reported that during a procedure, the heart-lung machine displayed "hl 30 is shutting down, please wait," then all pumps stopped.After turn-off and then turn-on, the device performed normally.Hand cranking the main pump was required while the device was re-starting.No pt effect was reported.(b)(4).
 
Manufacturer Narrative
A supplemental medwatch will be submitted when additional info becomes available.
 
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Brand Name
HL 30 CONSOLE BASE
Type of Device
HL 30 CONSOLE BASE
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
Manufacturer Contact
michael campbell
kehler strasse 31
rastatt 76437
GM   76437
2229321132
MDR Report Key4381224
MDR Text Key19613659
Report Number8010762-2014-01377
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K943803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHL 30
Device Catalogue Number70102.2096
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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