FDA Adverse Event
Malfunction
Summary report: N
HEARTSTREAM FR2
MDR report key: 2080985
·
Received April 13, 2011
Report
- Report Number
- 3030677-2011-00044
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Report Date
- March 30, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (HTST)
- Product Code
- MKJ
- PMA / PMN Number
- 003565
- Removal / Correction Number
- Z-0483-2011 THROUGH Z-04
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PENDING DEVICE EVAL.
Description of Event or Problem · 1
AED IS PART OF A RECALL POPULATION AND UPON RECEIPT IT FAILED SELF TEST.
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 |