MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-31 for EV1000 POWER ADAPTER EVPSB220L manufactured by Edwards Lifesciences.
[146907350]
The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product a supplemental report will be sent with the investigation results as well as a device history record review. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Patient Sequence No: 1, Text Type: N, H10
[146907351]
As reported, during use of this ev1000 system, there was smoke after the power cord had been plugged in. The user was not sure whether fire or sparks occurred since the power adapter had been kept inside a container, customized by hospital with the purpose of preventing saline/liquid from dropping onto the power supply. Priming of the transducer had not started yet, therefore there was no saline leakage into the adapter at that moment. It was clarified that there was no sound heard either. The nurse quickly unplugged the plug from the socket. After that, the power adapter was replaced with another one from a different ev1000 system. The ev1000m and databox were still functional, only the assembly power adapter was damaged. There was no allegation of patient injury. The device was available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01912 |
| MDR Report Key | 8656948 |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-05-03 |
| Date Mfgr Received | 2019-09-17 |
| Date Added to Maude | 2019-05-31 |
| 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 | MS. SAMANTHA EVELEIGH |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EV1000 POWER ADAPTER |
| Generic Name | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| Product Code | DXG |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-08-26 |
| Model Number | EVPSB220L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-31 |