FDA Adverse Event
Death
Summary report: N
FRX
MDR report key: 1743225
·
Received June 29, 2010
Report
- Report Number
- 3030677-2010-00213
- Event Type
- Death
- Date Received
- June 29, 2010
- Report Date
- June 29, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
- Product Code
- MKJ
- PMA / PMN Number
- 050004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
METHOD: ECG WAS REVIEWED FOR THIS INCIDENT. CONCLUSION: SUBJECT WAS IN A NON-SHOCKABLE RHYTHM, NO SHOCK WAS ADVISED AND NO SHOCK WAS DELIVERED. DEVICE DID NOT CAUSE OR CONTRIBUTE TO OUTCOME.
Description of Event or Problem · 1
SUBJECT WAS NOT RESUSCITATED. THE DATE OF THE INCIDENT IS UNK. (B) (4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FRX | AED | MKJ | PHILIPS MEDICAL SYSTEMS, HEARTSTREAM | 989803138201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |