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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number MCP00706291#ROTAFLOW PUMP MODULE
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2023
Event Type  malfunction  
Event Description
It was reported that the rotaflow machine was unplugged from electricity.The built-in power supply did not start, and the screen went black.However, the battery was shown as in standby state.The machine was moved to the manual mode, and electricity power was re-connected.The machine was, then, restarted and self-test were performed.No harm to any person has been reported.Prior to the use of the machine, the battery performance was checked, and no failures were found.Further information have been requested.Complaint id: (b)(4).
 
Manufacturer Narrative
A follow up will submitted when additional information become available.
 
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Brand Name
HEART LUNG MACHINE
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
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MDR Report Key18501444
MDR Text Key332899347
Report Number8010762-2024-00020
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K991864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMCP00706291#ROTAFLOW PUMP MODULE
Device Catalogue Number701046405
Is the Reporter a Health Professional? No
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2017
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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