MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-08-10 for 201-10002 manufactured by Thoratec Switzerland Gmbh.
[116874569]
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
[116874570]
It was reported that the console displayed an error message, "motor disconnected". The error message alarm was a continuous tone. The customer returned the suspected motor for evaluation and was given a loaner. This event was previously not reported due to no patient involvement. Abbott made the decision on (b)(6) 2018 to initiate a voluntary recall, therefore this event is being upgraded to reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2018-03415 |
| MDR Report Key | 7773777 |
| Report Source | FOREIGN |
| Date Received | 2018-08-10 |
| Date of Report | 2018-08-10 |
| Date of Event | 2014-08-05 |
| Date Mfgr Received | 2018-07-13 |
| Date Added to Maude | 2018-08-10 |
| 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 | TECHNOPARKSTRASSE 1 |
| Manufacturer City | ZURICH CH-8005 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-8005 |
| Manufacturer Phone | 78185 |
| Manufacturer G1 | THORATEC CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 95488 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95488 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MOTOR |
| Product Code | DSW |
| Date Received | 2018-08-10 |
| Returned To Mfg | 2014-10-13 |
| Catalog Number | 201-10002 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-08-10 |