MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-06 for EV1000 POWER ADAPTER EVPSB220L manufactured by Edwards Lifesciences.
[182341934]
Follow up is still ongoing regarding whether the product is expected to be returned for analysis. The serial number is unknown as well. 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
[182341935]
As reported, this evpsb220l, power supply of an ev1000a platform caught on fire. The device was removed immediately and no major incidents were reported. There was no injury to the patient or the staff personnel. Per further information provided, it was confirmed that the fire was only from the power supply and there were no sparks. There was no evidence of liquid dropped on the device. Follow-up ongoing regarding the device's availability for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10410 |
| MDR Report Key | 9679520 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-06 |
| 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 | 2020-02-06 |
| Model Number | EVPSB220L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-06 |