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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 Problems No Display/Image (1183); Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/20/2017
Event Type  malfunction  
Manufacturer Narrative
The replaced board was returned to livanova (b)(4) for further investigation. During evaluation, the reported failure was confirmed and the root cause was determined to be a faulty inductor could be identified. The board was scrapped.
 
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the s5 double head pump. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). A distributor engineer replaced an internal board to resolve the issue. 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 showed a graphical display error during a procedure. The touch screen reportedly did not function. There was no report of patient injury.
 
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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 Key6995200
MDR Text Key260320090
Report Number9611109-2017-00880
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K071318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2017
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?
Event Location No Information
Date Manufacturer Received02/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2016
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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