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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH MAG MONITOR CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH MAG MONITOR CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-30500
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2019
Event Type  malfunction  
Manufacturer Narrative
No patient was involved with the event. Manufacturer's investigation conclusion: the report of a centrimag mag monitor operating in a loading loop and not booting up fully was confirmed and reproduced during testing of the returned mag monitor (sn (b)(4)). The returned monitor was first received by the service depot. Upon arrival the mag monitor was checked for damage and none was observed. The unit was powered on. However, the unit did not boot up fully, confirming the reported event. The unit was forwarded to mcs zurich for troubleshooting and repair. The returned mag monitor was evaluated and tested at mcs zurich. The monitor was connected to a 2nd gen primary console via a test monitor cable. The console was connected to ac power and switched on. After powering the console on, the returned monitor started up but displayed a "loading application. " message and re-booted in a continuous loop. This fault occurred when both the left and right side monitor connections were used. The reported event was confirmed. The mag monitor was then disassembled in order to inspect its internal components. No connection issues nor visible damage were observed. The monitor pre-assembly printed circuit board (pcb) was removed and powered with a test monitor cable and a test "cable-lemo input", revealing that the reset-led on the cpu module was blinking in an interval of ~1 second on and ~30 seconds off. This was consistent with the observed continuous reset cycle. Further testing revealed that the exm32 cpu-module (sn (b)(4)) was responsible for the fault. The exm32 cpu-module is an externally supplied part. No circuit diagrams of the module are available. Therefore, no further analysis of the module could be performed. The root cause of this part being defective could not be conclusively determined during the investigation. The cpu-module was received at mcs zurich in december 2016. The manufacturer of the cpu-module provided a warranty guarantee until 31dec2018, and it was noted that this warranty has been exceeded. Review of the monitors device history record (dhr) revealed that it passed all tests prior to being sent to the customer. As a result, the root cause of the observed pcb damage could not be conclusively determined. The defective exm32 cpu-module was replaced with a new one, resolving the issue. The repaired unit was functionally tested and always operated as designed. The repaired and serviced unit was returned to the customer site. Reports of similar events will continue to be tracked and monitored. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
It was reported that the centrimag monitor was stuck in a loading loop and would not fully boot up. A different monitor was tested with the same cables and it booted up without issue. The suspect monitor was returned for evaluation. No additional information was provided.
 
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Brand NameMAG MONITOR
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 CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key9961755
MDR Text Key190940298
Report Number2916596-2020-02124
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30500
Device Lot NumberL06540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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