FDA Adverse Event
Death
Summary report: N
FR2
MDR report key: 1743444
·
Received June 29, 2010
Report
- Report Number
- 3030677-2010-00199
- Event Type
- Death
- Date Received
- June 29, 2010
- Report Date
- June 29, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
- Product Code
- MKJ
- PMA / PMN Number
- 003565
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INTERNAL MEMORY RELATED TO INCIDENT WAS REVIEWED. CONCLUSION: SUBJECT WAS IN A NON-SHOCKABLE RHYTHM (NO SHOCK WAS ADVISED/NO SHOCK DELIVERED.) DEVICE DID NOT CAUSE OR CONTRIBUTE TO OUTCOME.
Description of Event or Problem · 1
SUBJECT WAS NOT RESUSCITATED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FR2 | AED | MKJ | PHILIPS MEDICAL SYSTEMS, HEARTSTREAM | M3840A-ABS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |