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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE Back to Search Results
Model Number 201-90411
Device Problem Failure to Pump (1502)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: the device was returned for investigation. The evaluation is not yet complete. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that a centrimag gen 2 that was supporting a patient had a s3 alarm. The entire pump was exchanged. No further information provided.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of DevicePRIMARY CONSOLE
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CA CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CA CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key8620327
MDR Text Key145390739
Report Number2916596-2019-02211
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 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-90411
Device Catalogue Number201-90411
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/17/2019 Patient Sequence Number: 1
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