CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT L201-90411 201-90411

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-10 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT L201-90411 201-90411 manufactured by Thoratec Switzerland Gmbh.

Event Text Entries

[179792282] No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


[179792283] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916596-2020-00525
MDR Report Key9690001
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-10
Date of Report2020-03-06
Date of Event2020-01-23
Date Mfgr Received2020-02-26
Device Manufacturer Date2012-08-01
Date Added to Maude2020-02-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BOB FRYC
Manufacturer Street6035 STONERIDGE DRIVE
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal94588
Manufacturer Phone7818528204
Manufacturer G1THORATEC SWITZERLAND GMBH
Manufacturer StreetTECHNOPARKSTRASSE 1
Manufacturer CityZURICH CA CH-8005
Manufacturer CountrySZ
Manufacturer Postal CodeCH-8005
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT
Generic NameCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Product CodeDWA
Date Received2020-02-10
Returned To Mfg2020-01-29
Model NumberL201-90411
Catalog Number201-90411
Lot NumberIFS103676
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTHORATEC SWITZERLAND GMBH
Manufacturer AddressTECHNOPARKSTRASSE 1 ZURICH CH-8005 SZ CH-8005


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-10

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