MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-08-11 for CENTRIMAG MOTOR, OUS 201-10002 manufactured by Thoratec Switzerland Gmbh.
[116890720]
No patient was involved with the event. The device returned for analysis. The complaint investigation determined the reported difficulty was the result of a design related wear issue. After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag. Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.
Patient Sequence No: 1, Text Type: N, H10
[116890721]
The service engineer reported an event which occurred during preventive maintenance at a hospital (no patient was involved). It was found that a centrimag motor produced a? System alert: s3? At the associated 2nd generation console. When the error message occurred and the motor cable was moved, the error message disappeared. After fixing the motor cable with adhesive tape in order to keep it in place, the alert disappeared. However, it appeared again randomly. The description pointed to a problem in the motor cable. The device was tested at the distributor's technical service where it showed the same behavior. The suspect motor was therefore returned for analysis. This event was previously not reported due to no patient being involved with the event. Abbott made the decision on july 13, 2018 to initiate a voluntary recall, therefore this event is being upgraded to reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2018-03403 |
| MDR Report Key | 7775392 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-08-11 |
| Date of Report | 2018-08-11 |
| Date of Event | 2015-04-17 |
| Date Mfgr Received | 2018-07-13 |
| Date Added to Maude | 2018-08-11 |
| 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 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRIMAG MOTOR, OUS |
| Generic Name | MOTOR |
| Product Code | DSW |
| Date Received | 2018-08-11 |
| Model Number | 201-10002 |
| Catalog Number | 201-10002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-11 |