MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-03-15 for BURDICK ECLIPSE PREMIER E10-6AG17 NA manufactured by Cardiac Science Corporation.
[2629262]
The hospital's cardio-respiratory services mgr who reported the incident to cardiac science said one of their ecg machines had a "circuit board fire. " the hospital's clinical engineer dismantled the machine and found there were 2 surface mount components close to the power inlet that were charred. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
[9764557]
The hospital's clinical engineer found that there were 2 surface mount components that were charred and a picture of the board with the damaged components was sent to cardiac science. These components meet iec 60601 requirements and may have caused smoke when they failed, but would not have caused a fire. The failure resulted in the inability of the device to meet its essential function, but there was no hazard to the pt. At the present time, the facility does not intend to return the device or board to cardiac science for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3014398-2012-00002 |
| MDR Report Key | 2498824 |
| Report Source | 01,05 |
| Date Received | 2012-03-15 |
| Date of Report | 2012-02-24 |
| Date of Event | 2012-02-24 |
| Date Mfgr Received | 2012-02-24 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2012-03-21 |
| 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 | 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 PKWY |
| 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 | 2012-03-15 |
| Model Number | E10-6AG17 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIAC SCIENCE CORPORATION |
| Manufacturer Address | BOTHELL WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-15 |