FDA Adverse Event
Summary report: N
*
MDR report key: 3253793
·
Received July 25, 2013
Report
- Report Number
- 3253793
- Date Received
- July 25, 2013
- Date of Event
- September 1, 2012
- Report Date
- November 19, 2012
- Manufacturer
- CARDIAC SCIENCE CORPORATION
- Product Code
- MKJ
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
THE HOSPITAL HAS BEEN UNABLE TO REPLACE THE BATTERIES USED ON CARDIAC SCIENCE AED'S (MULTIPLE) DUE TO A BACKORDER OF BATTERIES FROM THE COMPANY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CHANGE AED BATTERIES.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347934 | * | DEFIBRILLATOR, AUTOMATED EXTERNAL | MKJ | CARDIAC SCIENCE CORPORATION | 9146-302 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |