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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS PRIMARY CONSOLE WITH ADULT FLOW PROBE

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS PRIMARY CONSOLE WITH ADULT FLOW PROBE Back to Search Results
Model Number 201-90401
Device Problem Pumping Stopped (1503)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2018
Event Type  malfunction  
Manufacturer Narrative
This medwatch is reporting the primary console. The motor is reported under medwatch mfr report # 2916596-2018-05625. The event occurred at (b)(6). No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
The patient was placed on extracorporeal membrane oxygenation (ecmo) support. It was reported that the pump suddenly stopped working. The healthcare professionals were able to get it to work again without having to exchange any equipment. The patient was not harmed or injured due to event. The patient remains stable on ecmo support. No additional information was provided.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS
Type of DevicePRIMARY CONSOLE WITH ADULT FLOW PROBE
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 Key8192714
MDR Text Key131797725
Report Number2916596-2018-05624
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/28/2019
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 Number201-90401
Device Catalogue Number201-90401
Device Lot Number5584897
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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