MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-28 for BURDICK ECLIPSE PREMIER E10-6AG17 NAQ manufactured by Cardiac Science Corporation.
[2702571]
The unit had a smell of smoke after an ecg and subsequently would not print.
Patient Sequence No: 1, Text Type: D, B5
[10097561]
A cardiac science field service engineer (fse) was dispatched to the customer's site and replaced the print head and power supply board. After replacing the parts, the fse tested the ecg cart and verified that it was functioning correctly. The replaced power supply board was returned to cardiac science for evaluation. The investigation confirmed that the power supply board was damaged and that component r39 was the cause of the failure. There were no other component failures. There were no other component failures. The board was scrapped.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3014398-2012-00012 |
| MDR Report Key | 2653132 |
| Report Source | 07 |
| Date Received | 2012-06-28 |
| Date of Report | 2012-05-30 |
| Date of Event | 2012-05-01 |
| Date Mfgr Received | 2012-05-30 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2012-10-18 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | 2012-06-28 |
| Model Number | E10-6AG17 |
| Catalog Number | NAQ |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-06-28 |