• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 06/21/2018
Event Type  malfunction  
Manufacturer Narrative
This report was initially submitted on (b)(6) 2018. The report was rejected due to an incorrect code and will no be resubmitted. Livanova (b)(4) manufactures the s5 double head pump. The incident occurred in (b)(6). The livanova field service representative who identified the issue was able to trace the failure to a faulty processor board. The board was replaced to resolve the error and subsequent functional verification testing was completed without further issues. The unit was returned to service. The board was returned to livanova (b)(4) for further investigation and the reported failure was confirmed during evaluation. A faulty transistor on the board was identified and determined to be the root cause. 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 issue is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report that an s5 double head pump displayed an error message during maintenance. This issue was discovered by a livanova field service representative during service. There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7709621
MDR Text Key114705308
Report Number9611109-2018-01094
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K071318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 07/20/2018
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 Other
Device Model Number10-85-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-