FDA Adverse Event
Death
Summary report: N
FR2
MDR report key: 1743230
·
Received June 29, 2010
Report
- Report Number
- 3030677-2010-00194
- Event Type
- Death
- Date Received
- June 29, 2010
- Report Date
- June 29, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS, HEARTSTREAM
- Product Code
- MKJ
- PMA / PMN Number
- 003565
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
METHOD: BASED ON ECG REVIEW AND DEVICE INTERNAL MEMORY ASSOCIATED WITH EVENT. CONCLUSION: ECG MORPHOLOGY CHANGED DURING INCIDENT. "NO SHOCK" WAS ADVISED AND NO SHOCKS WERE DELIVERED. BASED ON THE AVAILABLE INFO, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE INCIDENT.
Description of Event or Problem · 1
SUBJECT WAS NOT RESUSCITATED. DATE OF THE INCIDENT IS UNK. (B) (4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FR2 | AED | MKJ | PHILIPS MEDICAL SYSTEMS, HEARTSTREAM | M3840A-ABJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Death |