FDA Adverse Event
Other
Summary report: N
HEARTSTART FR2
MDR report key: 1574959
·
Received January 8, 2010
Report
- Report Number
- 3030677-2010-00001
- Event Type
- Other
- Date Received
- January 8, 2010
- Date of Event
- July 4, 2008
- Report Date
- January 8, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- 06365
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE INTERNAL MEMORY REVIEWED. DEVICE LABELING PROVIDES INFO REGARDING POTENTIAL REASONS FOR PAD CONTACT ISSUES (DRY SKIN, EXCESSIVE BODY HAIR, OILY SKIN, ETC.) REPORT IS BEING FILED DUE TO THE POTENTIAL FOR DELAY OF THERAPY.
Description of Event or Problem · 1
AED PROMPT INDICATED THAT PADS WERE NOT PROPERLY PLACED. RESPONDERS ATTEMPTED TO RE-APPLY 3X, AND PROMPTS CONTINUED. (B) (4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART FR2 | AED | MKJ | PHILIPS MEDICAL SYSTEMS | M 3860A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |