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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 Problems Device Alarm System (1012); No Display/Image (1183); Nonstandard Device (1420); Decreased Pump Speed (1500)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2019
Event Type  Injury  
Manufacturer Narrative
This event is originally reported under mfr # 2916596-2019-03237. The device was not returned for analysis. Similar reports has been investigated and the reported difficulty was the result of a design related issue. After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag. Abbott will perform a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis. The investigation will be submitted as a follow-up once it is complete.
 
Event Description
It was reported that the cmag console screen went blank and also gave a b4 error code. These both appear to have self corrected. This event was previously not reported due to the cmag motor not being part of the event. Abbott made the decision on (b)(6) 2019 to initiate a voluntary recall, therefore, this event is being upgraded to reportable.
 
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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 Key8955691
MDR Text Key156333760
Report Number2916596-2019-04222
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,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number102956
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/25/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberFA-Q319-MCS-1

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