Model note · Defibrillator
Philips HeartStart FRx Defibrillator 861304
The HeartStart FRx is a rugged, semi automatic AED for first responders, on sale since 2005. It delivers an impedance compensating SMART Biphasic shock of 150 J nominal for adults and 50 J for children when the blue Infant/Child Key is put in its slot, using SMART Pads II that suit all ages. It became a PMA device, P180028, on 11 May 2020. Its largest field action (2018, 660,519 FRx and HS1 units together) was a resistor that could stop the device from delivering a shock.
The model
Maker, model and type.
- Maker
- Philips Medical Systems
- Model
- HeartStart FRx Defibrillator 861304
- Device type
- Defibrillator
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA status | PMA P180028, approved 11 May 2020; first cleared in 2005 under K050004; product code MKJ | Source |
| System parts | FRx 861304, primary battery M5070A, aviation battery 989803139301, SMART Pads II 989803139261, Infant/Child Key 989803139311 | Source |
| Waveform and energy | Truncated exponential SMART Biphasic, impedance compensating; 150 J nominal adult, 50 J nominal infant and child | Source |
| Patients | Adults over 25 kg (55 lb); infants and children under 25 kg or 0 to 8 years with the Infant/Child Key; without the key, or if unsure of age or weight, treat as an adult | Source |
| Battery standby life | Lithium manganese dioxide primary battery; typical 4 years, minimum 3 years in standby with self tests | Source |
| Ruggedness | IPX5 against water jets; keeps performance after a 500 kg load on its top surface and after 0.5 m drops onto concrete on each axis | Source |
| Therapy endurance | At least 2500 charge and discharge cycles at rated energy into a 50 ohm load | Source |
| Controls and indicators | Readiness LED, green on/off, blue information (i) button, caution LED, flashing shock button, pad placement LEDs with pre connected pads cartridge, infrared data port | Source |
Recalls
Known FDA recalls.
- Z-0079-20222021-02-09
Customers had not been notified of earlier recalls on various defibrillator models.
FDA record - Z-1271-20202019-09-10
Printed circuit assembly not made or repaired to quality standards (44 units).
FDA record - Z-1913-20182018-03-14
A resistor issue could stop the device delivering a shock when needed (660,519 FRx and HS1 units).
FDA record - Z-1193-20102009-11-02
Possible capacitor failure during use, preventing effective defibrillation (544 units).
FDA record
Safety
Safety warnings from the record.
- Do not touch the patient while the caution LED is on, during analysis and shock; listed risks include bystander shock and skin burns at the pads. Source
- Fire hazard near high oxygen concentration or flammable anaesthetic agents. Source
- Philips later notified customers who had not received earlier recall letters for several defibrillator models, FRx included; check that every unit on the asset list has had each remedy. Source
Sources
Where this note comes from.
- FDA Summary of Safety and Effectiveness Data, PMA P180028, HeartStart FRx
- openFDA device recall records for the HeartStart FRx
- openFDA MAUDE problem counts for the HeartStart FRx
Not covered: Weight, charge time, the self test schedule and the voice prompt troubleshooting list are in the Philips Owner's Manual, which was not read for this draft. Check the waveform description against the Owner's Manual technical data before publishing.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Defibrillator