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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONTROL PANEL MRP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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LIVANOVA DEUTSCHLAND S5 CONTROL PANEL MRP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 28-95-80
Medical Device Problem Codes No Display/Image (1183); Pumping Stopped (1503)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/28/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 control panel mrp.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 or Problem Description
Livanova (b)(4) received a report that a s5 control panel mrp became blank and the pump stopped during procedure.The customer restarted the device to resolve the issue.There was no report of patient injury.
 
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Brand Name
S5 CONTROL PANEL MRP 150/85
Common Device Name
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
MDR Report Key7746246
Report Number9611109-2018-01130
Device Sequence Number11092550
Product Code DWB
UDI-Device Identifier04033817900818
UDI-Public010403381790081811171113
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 08/03/2018
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 the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/09/2018
Initial Report FDA Received Date08/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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