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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP CONTROL PANEL; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP CONTROL PANEL; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 28-95-80
Device Problems Decreased Pump Speed (1500); Increased Pump Speed (1501)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the s5 control panel mrp 150/85.The incident occurred in sheffield, united kingdom.A livanova field service representative was dispatched to the facility to investigate the device and confirmed the reported issue.The encoder was replaced and the problem solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
 
Event Description
Livanova deutschland received a report of a shaft encoder fault error on a s5 mast roller pump control panel during procedure.There was no report of patient injury.
 
Event Description
See initial report.
 
Manufacturer Narrative
H.10: the read-out analysis confirmed the reported issue.The root cause of the reported event is a defective shaft encoder.
 
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Brand Name
S5 MAST ROLLER PUMP CONTROL PANEL
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key10983621
MDR Text Key221298218
Report Number9611109-2020-00679
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
PMA/PMN Number
K071318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number28-95-80
Was the Report Sent to FDA? No
Date Manufacturer Received12/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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