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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE

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THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE Back to Search Results
Catalog Number 102954
Device Problems Battery Problem (2885); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2016
Event Type  malfunction  
Manufacturer Narrative
Patient demographics were requested but were not provided. Device unique identifier (udi) - device was manufactured prior to the udi labeling implementation. Approximate age of device - the centrimag primary console is not a single use device. Approximate age of the device from the ship date is 6 years, 8 months. The device was returned for investigation. The evaluation is not yet complete. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
The patient was being supported with an extracorporeal circulatory support device. It was reported that the primary console turned off when ambulating the patient. The console's battery reportedly died without any warning alarm that the battery was low. There was no reported adverse patient impact. Prior to the event, the console had remained plugged in until actual ambulation. The center's biomedical engineering department reported that the console ran less than 5 minutes on battery power. They confirmed that the battery was two or more years old. It was reported that the biomedical department plans to change out the batteries every 1. 5 years to prevent future occurrences. Further information was requested but not provided.
 
Manufacturer Narrative
The report of the centrimag primary console being unable to operate on battery power and not alarming for a low battery could not be confirmed or reproduced through the evaluation of the returned centrimag primary console. The battery maintenance procedure was performed to evaluate battery run time, and the unit passed with no issues. It was reported that the centrimag primary console had a battery replacement after the incident occurred. The battery that was in the primary console at the time of the event was not returned for evaluation; however, it was reported that the battery was over two years old. A review of the device history records showed no deviations from manufacturing or qa specifications. No further information was provided. The manufacturer is closing its file on this event.
 
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Brand NameTHORATEC CENTRIMAG PRIMARY CONSOLE
Type of DeviceCENTRIMAG PRIMARY CONSOLE
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
technoparkstrasse 1
pleasanton CA 94588
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
651756-407
MDR Report Key5636442
MDR Text Key44553081
Report Number2916596-2016-00865
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number102954
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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