FDA Adverse Event
Malfunction
Summary report: N
HEARTSTREAM FR2
MDR report key: 2013761
·
Received February 4, 2011
Report
- Report Number
- 3030677-2011-00008
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Report Date
- May 28, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (HTST)
- Product Code
- MKJ
- PMA / PMN Number
- 003565
- Removal / Correction Number
- Z-0470-2011/Z-0473-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD: DEVICE INTERNAL MEMORY WAS EVALUATED.
Description of Event or Problem · 1
DEVICE IS PART OF A RECALL POPULATION (Z-0470-2011 THROUGH Z-0473-2011). DURING THE SUBSEQUENT INTERNAL EVALUATION, THE PRODUCT WAS FOUND TO HAVE A COMPONENT FAILURE RELATED TO THE RECALL (U8 COMPONENT).
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 |