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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

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THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US Back to Search Results
Model Number 102956
Device Problem Circuit Failure (1089)
Patient Problem No Patient Involvement (2645)
Event Date 05/09/2019
Event Type  malfunction  
Manufacturer Narrative
The reported event of a motor fault failure was confirmed. The returned centrimag motor was tested. Per analysis, an open connection was found within the motor¿s cable when the cable was manipulated at the end of its bend relief during resistance testing. The open connection was found in the b2 line, which is responsible for the input and output current of bearing phase b2. An open connection in this line would cause motor disconnected: m2 alarms. An insulation test was also performed, and the motor passed insulation testing. The reported event was reproduced and confirmed. Upon connection to a test console and test flow probe, the console alarm with motor disconnected: m2. Due to the analysis deeming an open connection within the motor¿s cable, the motor was scrapped. The root cause of the motor fault appeared to be conductor breakdown within the motor¿s cable. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
It was reported that a motor failure alarm was noticed during clinical simulations. The console alarmed motor fault failure and was switched to a second motor. The alarm resolved. When the original motor was placed back on the console the alarm reappeared. The motor in question was not used on a patient. Motor was sent back for evaluation.
 
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Brand NameCENTRIMAG MOTOR, US
Type of DeviceCENTRIMAG MOTOR
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key9038376
MDR Text Key158677490
Report Number2916596-2019-04342
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 09/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number102956
Device Catalogue Number102956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberFA-Q318-MCS-1

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