• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US Back to Search Results
Model Number 102956
Device Problem Visual Prompts will not Clear (2281)
Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2018
Event Type  malfunction  
Manufacturer Narrative
Information was not provided. The motor is a single use device. The device has been returned but has not yet been investigated. No further information is available at this time. A supplemental report will be submitted with the manufacture investigation is completed.
 
Event Description
It was reported that the primary console indicated a system alert (s3) alarm. The primary console and motor were removed from service for return to the manufacturer for evaluation/repair. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8093030
MDR Text Key128066242
Report Number2916596-2018-05007
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2018
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 Manufacturer09/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/12/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-