FDA Adverse Event
Death
Summary report: N
HS1
MDR report key: 1743246
·
Received June 29, 2010
Report
- Report Number
- 3030677-2010-00192
- Event Type
- Death
- Date Received
- June 29, 2010
- Report Date
- June 29, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
- Product Code
- MKJ
- PMA / PMN Number
- 020715
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE INTERNAL MEMORY AND ECG FROM INCIDENT REVIEWED. CONCLUSION: SUBJECT WAS IN A NON-SHOCKABLE RHYTHM (ASYSTOLE), NO SHOCK WAS ADVISED AND NO SHOCK WAS DELIVERED. DEVICE DID NOT CAUSE OR CONTRIBUTE TO OUTCOME.
Description of Event or Problem · 1
DURING DEPLOYMENT, AED DID NOT ADVISE SHOCK. UPON ARRIVAL, EMS APPLIED MANUAL DEFIBRILLATOR AND WAS SUCCESSFUL IN RESUSCITATING THE SUBJECT. THE SUBJECT SUBSEQUENTLY EXPIRED IN THE HOSPITAL 2 / 3 DAYS LATER. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HS1 | AED | MKJ | PHILIPS MEDICAL SYSTEMS, HEARTSTREAM | M5066A-ABA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Death |