FDA Adverse Event
Malfunction
Summary report: N
HEARTSTREAM FR2
MDR report key: 2515195
·
Received March 29, 2012
Report
- Report Number
- 3030677-2012-00259
- Event Type
- Malfunction
- Date Received
- March 29, 2012
- Report Date
- January 11, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (HTST)
- Product Code
- MKJ
- PMA / PMN Number
- 003565
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVAL PENDING. ISSUE IS BEING REPORTED DUE TO POTENTIAL MALFUNCTION IN PRODUCT RETURNED 03/21/2012 IN CONJUNCTION WITH FIELD ACTION Z-0483.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT AED DID NOT PASS SELF DIAGNOSTIC CHECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTREAM FR2 | MKJ | PHILIPS MEDICAL SYSTEMS (HTST) | M3860A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |