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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 Problem Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 04/22/2018
Event Type  Injury  
Manufacturer Narrative
This event occurred at the (b)(6). Approximate age of device - 4 years. The centrimag console is not a single use device. Investigation conclusion: the reported event of a s3 alarm was confirmed. The centrimag 2nd generation primary console was returned to mcs zurich for analysis. The log file was downloaded from the console for review. A review of the downloaded log file showed the console operating as intended and displaying flow correctly until (b)(6) 2018. The sub fault ¿sf_ifd_flow_data¿ activated and triggered the ¿system alert: s3¿ in april, may, and november 2018 as well as january 2019. The returned console was connected to mains power supply and the returned and associated flow probe, test motor, test loop, and test pump were connected to the console. The unit was switched on and following the startup sequence alerted for ¿system alert: s3¿. The s3 alert could only be muted, but not cleared. The pump speed was increased to 1000 rpm; however, no flow was recorded when the speed was set. The system was able to operate at different pump speeds (500 rpm ¿ 5500 rpm). A test flow probe was connected to the console; however, still no flow was recorded. The console did not alarm when the flow probe was disconnected and was not able to recognize when the flow probe was reconnected. The console always showed blank flow. The ¿system alert: s3¿ alarm was still present when the console was powered on, and both the test and returned flow probe were not recognized by the console. The console¿s flow board was suspected for the problem with measuring and displaying the flow values. The console¿s original flow board was replaced with a new one and the console was switched on and was able to recognize both the test flow probe and the associated flow probe. The console registered flow as intended. The original flow board was determined to be defective. No further troubleshooting was able to be performed on the flow board due to the flow board being supplied by the external company, emtec/germany. No schematics are available. The repaired console was subjected to the repair and maintenance procedure with the associated flow probe and passed all tests. The s3 alert did not reoccur. The root cause for the reported s3 alarm was conclusively determined to be due to a defective flow board. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
It was reported that a centrimag console gave s3 alarms. There was no patient involvement with this event. No further 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 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 Key8842042
MDR Text Key152673285
Report Number2916596-2019-03682
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeSA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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