FDA Adverse Event
Death
Summary report: N
AGILENT FORERUNNER DEFIBRILLATOR
MDR report key: 450410
·
Received March 28, 2003
Report
- Report Number
- 3030677-2003-00046
- Event Type
- Death
- Date Received
- March 28, 2003
- Date of Event
- February 28, 2003
- Report Date
- February 28, 2003
- Manufacturer
- AGILENT TECHNOLOGIES
- Product Code
- MKJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- EMERGENCY MEDICAL TECHNICIAN
Narratives
Description of Event or Problem · 1
DURING A RESPONSE, THE DEFIBRILLATOR WOULD NOT ADVISE A SHOCK ON THE PT WITH SEVERE PSORIASIS AND A PRESENTING VENTRICULAR FIBRILLATION RHYTHM. THE DEFIBRILLATOR CONTINUALLY ADVISED THE USER TO PRESS THE PADS FIRMLY ONTO THE CHEST. FOUR SETS OF PADS WERE USED WITH TWO DIFFERENT DEFIBRILLATORS, NEITHER OR WHICH OBTAINED SUITABLE PADS CONTACT TO ANALYZE AND ADVISE A SHOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AGILENT FORERUNNER DEFIBRILLATOR | SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR | MKJ | AGILENT TECHNOLOGIES | E01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Death |