MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-06-06 for BURDICK ECLIPSE PREMIER E10-6AG17 manufactured by Cardiac Science Corporation.
[2782976]
A field service engineer (fse) was dispatched to customer site to replace the power supply pcb in their eclipse premier. After replacing the power supply and powering the unit on, the fse heard a slight crackling sound and notice serve thermal break down was occurring on one of the power supply board components. A replacement unit was sent to the customer and the unit in question is being returned for failure investigation.
Patient Sequence No: 1, Text Type: D, B5
[10082394]
The unit has been returned to the mfr and an investigation is currently taking place. An additional evaluation report will follow.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3014398-2008-00014 |
| MDR Report Key | 2690014 |
| Report Source | 00 |
| Date Received | 2008-06-06 |
| Date of Report | 2008-06-06 |
| Date of Event | 2008-05-08 |
| Date Mfgr Received | 2008-05-08 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2012-08-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BEV MAGRANE |
| Manufacturer Street | 3303 MONTE VILLA PKWY. |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer Phone | 4254022365 |
| Manufacturer G1 | CARDIAC SCIENCE CORPORATION |
| Manufacturer Street | 500 BURDICK PARKWAY |
| Manufacturer City | DEERFIELD WI 53531969 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53531 9692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURDICK ECLIPSE PREMIER |
| Generic Name | RESTING ECG SYSTEM |
| Product Code | LOS |
| Date Received | 2008-06-06 |
| Model Number | E10-6AG17 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIAC SCIENCE CORPORATION |
| Manufacturer Address | BOTHELL WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-06 |