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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number L201-90411
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 07/10/2019
Event Type  Injury  
Manufacturer Narrative
The reported motor had been reported under mfr # 916596-2019-03691. Approximate age of device ¿ 2 years 4 months 26 days. No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
It was reported that the main console would not power up. The customer returned both the console and motor and are requesting new products. No additional information was reported.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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 Key8847608
MDR Text Key152845589
Report Number2916596-2019-03690
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model NumberL201-90411
Device Catalogue NumberL201-90411
Device Lot Number7063214
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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