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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONTROL PANAL MRP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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LIVANOVA DEUTSCHLAND S5 CONTROL PANAL MRP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 28-95-80
Medical Device Problem Code No Display/Image (1183)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/27/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 control panel mrp 150/85.The incident occurred in (b)(6).The device has been requested for return to livanova deutschland for investigation.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 or Problem Description
Livanova (b)(4) received a report that the display of an s5 control panal mrp became blank during a procedure and the user was unable to control the pump.There was no report of patient injury.
 
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Brand Name
S5 CONTROL PANAL MRP 150/85
Common Device Name
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM  80939
MDR Report Key7151632
Report Number9611109-2017-01049
Device Sequence Number18867119
Product Code DWB
UDI-Device Identifier04033817900818
UDI-Public010403381790081811170627
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K071318
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number28-95-80
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/04/2017
Initial Report FDA Received Date12/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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