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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE

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THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE Back to Search Results
Model Number 102954
Device Problem Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2018
Event Type  Injury  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr. Report # 2916596-2018-00848. This report is being submitted as additional information. The patient age, weight, gender were requested but were not provided. Approximate age of device- 6 years, 11 months (calculated from date of manufacture). Manufacturer's investigation conclusion: the reported event was confirmed through the evaluation of the returned centrimag console; however, a root cause could not be determined. The returned centrimag console was checked for internal and external damage upon receipt and no damage was observed. The console history maintenance card was inspected and it was noted that no maintenance was performed since 11-mar-2011. The console was charged overnight in order to perform battery maintenance test. Upon removing ac power during the battery maintenance test, the console shut down after a minute of run time, confirming the reported event. The old battery was replaced. A full functional checkout was performed and all tests passed. A warning label was installed and instructions were included. The console will be returned to the customer site. The centimag primary console operating manual shows how to identify the power source in use and the charge remaining in the internal battery. It also outlines internal rechargeable battery pack replacement and maintenance (rechargeable battery pack must be replaced every 2 years and battery maintenance should be performed once every 6 months) and outlines the operator responses to all primary console alarms and alerts. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
The patient was being supported with an extracorporeal circulatory support pump. It was reported that the centrimag (cmag) primary console¿s internal battery depleted when the patient was being transported by emergency medical services (ems). It is unknown if the patient was adversely impacted by the event. Additional information was requested but not provided.
 
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Brand NameCENTRIMAG 1ST 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 Key8656636
MDR Text Key146634471
Report Number2916596-2019-02598
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093832
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
Report Date 05/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number102954
Device Catalogue Number102954
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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