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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC ADULT FLOW PROBE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH EM-TEC ADULT FLOW PROBE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-30105
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2020
Event Type  malfunction  
Manufacturer Narrative
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 centrimag console alarmed battery module fail twice and the alarm hasn't repeated. The doctor was at the bedside when this happened and elected not to change the console. It was reported it was advised to keep a backup available and not transport the patient without being informed. The battery indicator shows 3. 45h and the console has been plugged in the entire time. The rpms were 3800 with 4. 5 l/min flow. No adverse event reported, and no additional information reported.
 
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Brand NameEM-TEC ADULT FLOW PROBE
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 CA CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key9690044
MDR Text Key179791704
Report Number2916596-2020-00526
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30105
Device Catalogue Number201-30105
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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