MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-07-12 for BURDICK ECLIPSE PREMIER 671-1001-01U NA manufactured by Cardiac Science Corporation.
[2840372]
Customer reported that the ecg unit had smoked.
Patient Sequence No: 1, Text Type: D, B5
[10057569]
A replacement power supply board was sent to the customer and the original board was returned for evaluation. The problem occurred due to a component failure on the board.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3014398-2012-00013 |
| MDR Report Key | 2659988 |
| Report Source | 07 |
| Date Received | 2012-07-12 |
| Date of Report | 2012-06-13 |
| Date of Event | 2012-06-01 |
| Date Mfgr Received | 2012-06-13 |
| Date Added to Maude | 2012-11-05 |
| 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 | 2012-07-12 |
| Returned To Mfg | 2012-06-27 |
| Model Number | 671-1001-01U |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIAC SCIENCE CORPORATION |
| Manufacturer Address | BOTHELL WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-12 |