FDA Adverse Event
Other
Summary report: N
HEARTSTREAM FR2
MDR report key: 2500851
·
Received March 20, 2012
Report
- Report Number
- 3030677-2012-00228
- Event Type
- Other
- Date Received
- March 20, 2012
- Report Date
- February 27, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (HTST)
- Product Code
- MKJ
- PMA / PMN Number
- 003565
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). OTHER REPORTABLE EVENT: THIS IS BEING REPORTED AS THE CUSTOMER IS INQUIRING ABOUT THEIR PADS AFTER A USE EVENT. PT OUTCOME IS UNKNOWN.
Description of Event or Problem · 1
AED WAS DEPLOYED, AND THE USER HAD A CONCERN ABOUT THE COLOR OF THE PADS GEL AFTER DEPLOYMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTREAM FR2 | MKJ | PHILIPS MEDICAL SYSTEMS (HTST) | M3841A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |