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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-85-00
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Patient Involvement (2645)
Event Date 05/21/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the s5 double head pump. The incident occurred in (b)(6). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.
 
Event Description
Livanova (b)(4) received a report that an s5 double head pump displayed an error message during priming. There was no patient involvement.
 
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Brand NameS5 DOUBLE HEAD PUMP
Type of DeviceCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key7709618
MDR Text Key114671924
Report Number9611109-2018-01096
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeGG
PMA/PMN Number
K071318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10-85-00
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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