MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-02 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE 201-90411 manufactured by Thoratec Switzerland Gmbh.
[179424301]
Patient weight not provided. 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
[179424302]
The site reported the centrimag console displayed a b4 battery alarm. The patient was switched to a back-up console. The site attempted to run the battery re-conditioning on 2 console without success. No further information was reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2916596-2019-06119 |
MDR Report Key | 9541964 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2020-01-02 |
Date of Report | 2020-03-19 |
Date of Event | 2019-12-10 |
Date Mfgr Received | 2020-03-18 |
Device Manufacturer Date | 2016-04-03 |
Date Added to Maude | 2020-01-02 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. BOB FRYC |
Manufacturer Street | 6035 STONERIDGE DRIVE |
Manufacturer City | PLEASANTON CA 94588 |
Manufacturer Country | US |
Manufacturer Postal | 94588 |
Manufacturer Phone | 7818528204 |
Manufacturer G1 | THORATEC SWITZERLAND GMBH |
Manufacturer Street | TECHNOPARKSTRASSE 1 |
Manufacturer City | ZURICH CA CH-8005 |
Manufacturer Country | SZ |
Manufacturer Postal Code | CH-8005 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CENTRIMAG 2ND GENERATION PRIMARY CONSOLE |
Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
Product Code | DWA |
Date Received | 2020-01-02 |
Model Number | 201-90411 |
Catalog Number | 201-90411 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | THORATEC SWITZERLAND GMBH |
Manufacturer Address | TECHNOPARKSTRASSE 1 ZURICH CA CH-8005 SZ CH-8005 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-01-02 |