FDA Adverse Event
Other
Summary report: N
HEARTSTART ONSITE
MDR report key: 1574955
·
Received January 8, 2010
Report
- Report Number
- 3030677-2010-00003
- Event Type
- Other
- Date Received
- January 8, 2010
- Report Date
- January 8, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 0207015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE INTERNAL MEMORY REVIEWED. RESULT: REVIEW INDICATED ANALYSIS INTERRUPTED BY HANDLING ARTIFACT. CONCLUSION: THIS REPORT IS BEING FIELD AS IT CANNOT BE CONCLUSIVELY STATED THAT RECURRENCE WOULD NOT RESULT IN AN ADVERSE EVENT.
Description of Event or Problem · 1
AED DID NOT SHOCK VFIB. (B) (4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART ONSITE | AED | MKJ | PHILIPS MEDICAL SYSTEMS | M5067A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |