FDA Adverse Event Death Summary report: N

FR2

MDR report key: 1880141 · Received October 20, 2010

Report

Report Number
3030677-2010-00340
Event Type
Death
Date Received
October 20, 2010
Date of Event
October 11, 2010
Report Date
October 20, 2010
Manufacturer
PHILIPS MEDICAL SYSTEMS
Product Code
MKJ
PMA / PMN Number
03565
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

ASSESSMENT OF DEVICE PENDING.

Description of Event or Problem · 1

AED DEPLOYED TO ATTEMPT RESUSCITATION. SUBJECT WAS NOT RESUSCITATED. (DEVICE # 2) (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FR2 AED MKJ PHILIPS MEDICAL SYSTEMS M3860A-ABU

Patients

Seq Age Sex Outcome Treatment
1 Death