FDA Adverse Event
Other
Summary report: N
HEARTSTART FRX
MDR report key: 2671034
·
Received July 20, 2012
Report
- Report Number
- 3030677-2012-00843
- Event Type
- Other
- Date Received
- July 20, 2012
- Report Date
- June 25, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD: PT ICG WAS EVALUATED. CONCLUSION: DEVICE PROPERLY ADVISED NO SHOCK ON A NON-SHOCKABLE RHYTHM.
Description of Event or Problem · 1
CUSTOMER QUESTIONED SHOCK DECISION OF DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART FRX | MKJ | PHILIPS MEDICAL SYSTEMS | 861304 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |