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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 201-30300
Device Problems No Display/Image (1183); Decreased Pump Speed (1500)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2019
Event Type  Injury  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
The patient was supported by an extracorporeal circulatory support device starting on (b)(6) 2019. It was reported that the an ¿s3 system alert¿ was observed. The rpm¿s went from 4500 to 3500 and flow through the sensor was not reading on the console screen. After consulting the troubleshooting guide, i tried acknowledging the alarm, but there was no resolution. Per the guide, we moved to the backup console, centrifugal motor and flow probe. The situation resolved immediately. There was no adverse event as a result of s3 system alert. No additional information was 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 CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key8905979
MDR Text Key154728479
Report Number2916596-2019-04047
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 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30300
Device Catalogue Number201-30300
Device Lot NumberL06379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/19/2019 Patient Sequence Number: 1
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