FDA Adverse Event
Death
Summary report: N
HS1
MDR report key: 1833159
·
Received September 2, 2010
Report
- Report Number
- 3030677-2010-00310
- Event Type
- Death
- Date Received
- September 2, 2010
- Date of Event
- January 1, 2009
- Report Date
- September 2, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
- Product Code
- MKJ
- PMA / PMN Number
- 021715
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPORTER NOTED THAT HE DESTROYED DEVICE. METHOD: THIS REPORT IS BEING FILED BASED ON ANECDOTAL INFO FROM REPORTER. INFO WAS PROVIDED WHEN REPORTER WAS CONTACTED IN CONJUNCTION WITH UNRELATED REMEDIAL ACTION (B)(4). THIS REPORT IS BEING FILED AS THERE IS INSUFFICIENT INFO TO DETERMINE ASSOCIATION/LACK OF ASSOCIATION OF DEVICE WITH EVENT OUTCOME.
Description of Event or Problem · 1
EXACT DATE OF EVENT UNK (2009). AED DEPLOYED AND SHOCK DELIVERED. SUBJECT WAS NOT RESUSCITATED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HS1 | AED | MKJ | PHILIPS MEDICAL SYSTEMS, HEARTSTREAM | M5068A-C01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |