MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-09-04 for BURDICK ECLIPSE PREMIER E10-6AG17 NA manufactured by Cardiac Science Corporation.
[3778622]
The customer's biomedical engineer installed a new power supply board from cardiac science into the device and when it was returned on, the power supply board smoked. The device was not being used with a pt when the problem occurred.
Patient Sequence No: 1, Text Type: D, B5
[11137457]
The biomedical engineer examined the power supply board and determined that component r34 was charred. A replacement power supply board was sent to the customer. The customer was asked to return the faulty power supply board to cardiac science for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009249335-2013-00013 |
| MDR Report Key | 3415917 |
| Report Source | 00,05 |
| Date Received | 2013-09-04 |
| Date of Report | 2013-08-05 |
| Date of Event | 2013-08-01 |
| Date Mfgr Received | 2013-08-05 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2013-12-04 |
| 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 | N7 W22025 JOHNSON DR |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2629537951 |
| 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 | 2013-09-04 |
| 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 | WAUKESHA WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-04 |