FDA Adverse Event
Death
Summary report: N
FR2
MDR report key: 1743234
·
Received June 29, 2010
Report
- Report Number
- 3030677-2010-00188
- 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
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ECG WAS REVIEWED FOR THIS INCIDENT. RESULT: ECG MORPHOLOGY CHANGED DURING INCIDENT. AED ADVISED SHOCK AND CHANGED TO "NO SHOCK ADVISED".
Description of Event or Problem · 1
SUBJECT WAS NOT RESUSCITATED. DATE OF THE EVENT IS UNK. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FR2 | AED | MKJ | PHILIPS MEDICAL SYSTEMS, HEARTSTREAM | M3841A-ABF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Death |