FDA Adverse Event
Death
Summary report: N
HEARTSTART ONSITE
MDR report key: 2202641
·
Received August 5, 2011
Report
- Report Number
- 3030677-2011-00117
- Event Type
- Death
- Date Received
- August 5, 2011
- Report Date
- August 2, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (HTST)
- Product Code
- MKJ
- PMA / PMN Number
- 020715
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CURRENTLY PENDING EVALUATION OF THE DEVICE AND INCIDENT.
Description of Event or Problem · 1
DURING DEPLOYMENT, THE SUBJECT WAS NOT RESUSCITATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART ONSITE | MKJ | PHILIPS MEDICAL SYSTEMS (HTST) | M5066A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |