FDA Adverse Event
Malfunction
Summary report: N
HEARTSTREAM FR2
MDR report key: 2343246
·
Received November 2, 2011
Report
- Report Number
- 3030677-2011-00186
- Event Type
- Malfunction
- Date Received
- November 2, 2011
- Report Date
- May 31, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (HTST)
- Product Code
- MKJ
- PMA / PMN Number
- 003565
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION - THIS REPORT IS BEING FILED AS IT CANNOT BE CONCLUDED THAT RECURRENCE WOULD NOT RESULT IN AN ADVERSE EVENT.
Description of Event or Problem · 1
RETROSPECTIVE REPORT PER 803.50(A), MDR #3030277-2011-00066. DEVICE DISPLAY MALFUNCTION.
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 |