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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 701043306
Device Problems No Audible Alarm (1019); Alarm Not Visible (1022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2019
Event Type  malfunction  
Manufacturer Narrative
A supplemental medwatch will be submitted after new information has been received.
 
Event Description
In (b)(6) it was reported that the hl20 device has no alarm when the liquid level is lower than the specified value.No indication of actual harm or death.(b)(4).
 
Event Description
(b)(4).
 
Manufacturer Narrative
According to the communication with getinge field service technician, following works were done: a getinge fiel service technician was onsite and investigated the device in question.The service technician cleaned the sensor and the issue was solved.The technician confirmed that the unit is working properly and the device was returned for clinical use.The most probable root cause could be determined as dust or dirt related issue.Failure could be confirmed.The ocurrance 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.
 
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Brand Name
HEART LUNG MACHINE
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
MDR Report Key9021102
MDR Text Key194815811
Report Number8010762-2019-00282
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
PMA/PMN Number
K943803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number701043306
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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