FDA Adverse Event
Other
Summary report: N
HEARTSTART FR2+
MDR report key: 1611170
·
Received February 12, 2010
Report
- Report Number
- 3030677-2010-00015
- Event Type
- Other
- Date Received
- February 12, 2010
- Date of Event
- January 15, 2010
- Report Date
- February 12, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 06365
- Removal / Correction Number
- Z-00063-2010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE INTERNAL MEMORY REVIEWED. CONCLUSION - REPORT FILED BECAUSE, IT CANNOT BE CONCLUSIVELY STATED THAT REOCCURRENCE WOULD NOT LEAD TO DELAY OF THERAPY.
Description of Event or Problem · 1
PRODUCT WAS RETURNED AS PART OF RECALL Z-00063-2010. DURING INTERNAL EVALUATION WAS FOUND TO HAVE MEMORY CHIP FAILURE. NOTE: DATE OF EVENT NOTED CORRESPONDS WITH DATE OF INTERNAL EVALUATION. (B) (4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART FR2+ | AED | MKJ | PHILIPS MEDICAL SYSTEMS | M3860A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |