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U.S. Department of Health and Human Services

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

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THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR MOTOR, RENTAL Back to Search Results
Model Number L102956
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2018
Event Type  malfunction  
Manufacturer Narrative
The motor is not a single use device. Approximate age of the device is will be determined based on the manufacturer date of the device. No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
It was reported that threads on the motor where it attaches to the motor bracket were stripped out. The issue was found during set up of the motor upon receipt by the site. No alarms were reported. There was no patient involved in this event.
 
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Brand NameCENTRIMAG MOTOR
Type of DeviceMOTOR, RENTAL
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 Key8192611
MDR Text Key131487003
Report Number2916596-2018-05785
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
Type of Report Initial,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberL102956
Device Catalogue NumberL102956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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