MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-12 for CENTRIMAG 2ND GENERATION PRIMARY CONSOLE 201-90411 manufactured by Thoratec Switzerland Gmbh.
[181786538]
This report addresses the console. The motor is reported under mfr. #2916596-2020-00795. 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
[181786539]
It was reported that while the patient was on extracorporeal membrane oxygenation (ecmo) support, the motor became noisy and very warm, and a burning smell was noted. As the healthcare provider was powering up the backup console, the console in use went blank (no lights or power) and the motor stopped. The motor was exchanged. Ecmo support was discontinued on (b)(6) 2019. The event was reported to have been resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-00796 |
| MDR Report Key | 9703505 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-11-16 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-12 |
| 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 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 | 2020-02-12 |
| Model Number | 201-90411 |
| Catalog Number | 201-90411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC SWITZERLAND GMBH |
| Manufacturer Address | TECHNOPARKSTRASSE 1 ZURICH CH-8005 SZ CH-8005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |