MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-30 for HEARTMATE MOBILE POWER UNIT, EU 107758 manufactured by Thoratec Corporation.
[187038968]
Manufacturer investigation conclusion: the reported event, of damaged o-rings in the mpu power lead connectors, was confirmed when the unit was checked by technical service. Both the o-rings on both the black and white power cable connectors were worn and frayed. The mpu patient cable was replaced. The mpu battery door was also damaged; the bottom housing was replaced. The software on the mpu was upgraded to the current version. The mpu was tested and returned to the rental/loaner pool. No further information was provided. The manufacturer is closing the file on this event.
Patient Sequence No: 1, Text Type: N, H10
[187038969]
It was reported that the device was returned for routine maintenance. The technician recognized a damaged connector isolation. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01443 |
| MDR Report Key | 9901231 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-09-30 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2016-04-26 |
| Date Added to Maude | 2020-03-30 |
| 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 CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 95488 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95488 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE MOBILE POWER UNIT, EU |
| Generic Name | VENTRICULAR (ASSISST) BYPASS |
| Product Code | DSQ |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2019-10-31 |
| Model Number | 107758 |
| Catalog Number | 107758 |
| Lot Number | 173585 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | 6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |