Philips Produce Defect Correction – Devices supplied with power cord which does not conform to IEC60601-1 standard – November 2022
Philips, the manufacturer of CPAP and Bi-Level PAP devices has issued a Produce Defect Correction that affects the following devices:
1111145 – BiPAP A30, Australia
1111171 – BiPAP A40, Australia
1132554 – DreamStation Go – Power Cord, 10 FT, Aus
AU201S – REMSTAR PLUS M, W/SMRTCRD, AUST
AU401HS – REMSTAR PRO M, W/HUMID, W/SMRTCRD, AUST
AU401S – REMSTAR PRO M W/SMRTCRD, AUST
AU451HS – REMstar Pro C-Flex+ W/HUMID, SD Card,AUS
AU451S – REMstar Pro C-Flex+ W/SD Card, AUS
AU461HS – REMstar Pro C-Flex w/Hum,SysOne60Srs,AUS
AU461S – REMstar Pro C-Flex+, Sys One, 60Srs,AUS
AU461TS – REMstar ProCFlex+w/HTHumSysOne,60Srs,AUS
AU501S – REMSTAR AUTO M, W/SMRTCRD, AUST
AU511S – REMSTAR AUTO M W/SMRTCRD, AFLEX, AUST
AU551S – REMstar Auto A-Flex W/SD Card, AUS
AU561S – REMstar AutoA-Flex w/Hum,SysOne60Srs,AUS
AU561TS – REMstar AutoA-Flex w/HTHumSysOne60Srs,AUS
AU701S – BIPAP AUTO M, W/SMRTCRD, AUST
AU751S – BiPAP Auto BiFlex,W/SD Card, AUS
AUG400H15 – DreamStation Go CPAP w/Humid, AUS
AUG400S15 – DreamStation Go w/BT, AUS
AUG500H15 – DreamStation Go Auto CPAP w/Humid, AUS
AUG500S15 – DreamStation Go Auto w/BT, AUS
AUX1131S15 – DreamStation BiPAP AVAPS30AE AAM,AU
AUX1131T15 – DreamStation BiPAP AVAPS30AE AAM H/HT,AU
AUX3000S19 – BiPAP A40 EFL, AU
AUX3100S19 – BiPAP A40 Pro, AU
AUX400S15 – DreamStation CPAP Pro, AUS
AUX400T15 – DreamStation CPAP Pro w/Humid/HT, AUS
AUX400T15C – DreamStation CPAP Pro w/Hum/HT/Cell, AUS
AUX500S15 – DreamStation Auto CPAP, AUS
AUX500T15 – DreamStation Auto CPAPO w/Humid/HT, AUS
AUX500T15C – DreamStation Auto CPAP w/Hum/HT/Cell, AU
AUX700S15 – DreamStation Auto BiPAP, AUS
AUX700T15 – DreamStation Auto BiPap w/Humid/HT, AUS
AUX700T15C – DreamStation Auto BiPAP/Hum/HT/Cell,AUS
AUX900S15 – DreamStation BiPAP autoSV, AU
AUX900T15 – DreamStation BiPAP autoSV H/HT, AU
AUX900T15C – DreamStation BiPAP autoSV H/HT/C, AU
The manufacturer, Philips, has issued a Product Defect Correction for the power cord used on many of its CPAP and BiPAP devices as it does not conform to IEC60601-1 standard.
The BiPAP A40, BiPAP A30, BiPAP Auto System One 60 series, BiPAP AVAPS C Series, BiPAP A40 Pro, BiPAP A40 EFL, DreamStation, REMstar, Simply Go devices were supplied with a IEC52 (H02) power cord “light duty cord” instead of an IEC53 (H05) power cord “ordinary duty cord”.
The light duty cord will successfully provide power to the affected devices.
IEC60601-1 requires medical devices to be supplied with an “ordinary” PVC sheathed cord (IEC53). The ordinary duty cord can withstand humidity and mechanical stresses better than the light duty cord. Continued use of the light duty power cord remains safe in the home setting. Users should follow general safety precautions when handling the cords, including but not limited to:
- Keeping the cords away from high traffic areas
- Holding the plug when pulling the cord form a power socket
- Keeping the cord away from heat sources; and
- Only use power cords and cables provided by Philips Australia for use with the affected devices. Use of power cords and cables not recommended by Philips Australia may cause overheating or damage to the device.
The device can continue to be safely used with its original IEC52 power cord provided the general safety precautions outlined above are followed. Please refer to the relevant instructions for use, as supplied with the device.
You may fill out the Patient Acknowledgement Form by visiting https://philips.to/3qGMdB5
Based on the information above, if you feel you want your power cord replaced, please also visit https://philips.to/3qGMdB5.
Important information about Philips CPAP and Bi-Level PAP machine product recall – July 2021
Philips, the manufacturer of CPAP and Bi-Level PAP devices has recalled many of its machines due to safety concerns.
Philips Australia has provided further information and a full list of devices affected on their website, available here.
The following information is from the TGA website:
If you are affected by the Philips product recall, or if you have any questions about your CPAP machine, please contact our Bridge Mall Pharmacy.
If you are suffering from sleep apnoea, your airways become blocked while you are sleeping and can remain blocked from just seconds to up to a full minute.
The brain will register the lack of breathing or the drop in oxygen levels and will send a wakeup call. This pattern can be repeated hundreds of times a night and the sufferer will wake in the morning feeling unrested, leading to poor concentration and fatigue.
Snoring and Sleep Apnoea
Symptoms of sleep apnoea include snoring, daytime sleepiness, poor concentration and mood changes.
The most effective treatment for sleep apnoea is a mask worn at night that prevents the throat from collapsing, by transmitting increased air pressure to the collapsible segment of the throat. This is called ‘nasal continuous positive airway pressure’ (CPAP). The key to this treatment is finding a mask and machine that match your needs.