FDA Adverse Event
Death
Summary report: N
HEARTSTREAM FR2
MDR report key: 2133370
·
Received June 16, 2011
Report
- Report Number
- 3030677-2011-00088
- Event Type
- Death
- Date Received
- June 16, 2011
- Report Date
- May 20, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (HTST)
- Product Code
- MKJ
- PMA / PMN Number
- 003565
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CURRENTLY PENDING DEVICE EVALUATION.
Description of Event or Problem · 1
DURING AED DEPLOYMENT, THE SUBJECT WAS NOT RESUSCITATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTREAM FR2 | MKJ | PHILIPS MEDICAL SYSTEMS (HTST) | M3840A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Death |