for Philips VS3 and VS4
Does anyone know what software upgrade FSN86000266B is about? We haven't gotten anything from Philips but an outside firm is asking to come on-site to do remediation. Please let me know what the upgrade is for!
We may have done it already, but I can't seem to find any information and the outside firm is not very informative. They insist that it won't cost us anything, but wont give me any more information
Thu Jun 17 2021
software upgrade FSN86000266B.
Thu Jun 17 2021Reply from Ray Brown, CBET
Are you certain you have that FSN number right? Ending in 255 or 256? Those came out in 2019, specifically to force the vital sign machines to track the number of cycles (300) or number of years (3) of use, and to remind the operator that the battery needs to be replaced if those numbers are reached or exceeded. Philips came out with an 18-page notice of this detailing how to install the software. I have been told that our facility declined the software upgrade. Your mileage may vary.
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Fri Jun 18 2021Reply from rsiefers
that is the ony notice I have received
the most recent reply states FCO266, but the company handling this for Philips is very vague on what this software upgrade is about. Can someone please elaborate.
Thanks
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Tue Jun 22 2021Reply from Chris S
FCO86000266B
Philips has received a report in which the Philips SureSigns VS4 monitors with software version A.05.47 and above, has the potential of not measuring, displaying and alarming pulse rates above 240 beats per minute (bpm) with the Philips FAST (Fourier Artifact Suppression Technology) SpO2 functionality is enabled. The monitor will display pulse rate as "?" bpm with no alarms above 240 bpm.
Although the Philips SureSigns VS4 Instructions for Use indicate the Philips Fast SpO2 can measure, display and alarm for pulse rate above 240 beats per minutes, the software does not.
In addition, the existing labeling does not include a warning for the alarm settings limitation of the Masimo rainbow SET technology for pulse rate values. The Masimo rainbow SET Technology pulse rate value is only up to 240 beats per minute.
Cause : The Philips FAST SpO2 pulse rate value in, software A.05.47 and above were set to 240 beats per minutes, the same as the Masimo rainbow SET Technology pulse rate values.
Remedy : Philips is issuing a customer installable, software update for the SureSigns monitors (VS3/VS4) that will:
- Provide the ability to measure, display and alarm for pulse rate above 240 beats per minute with the Philips FAST SpO2 functionality.
- Correct "nmhg" on the "Hide Patient Record" screen to display "mmHg"
Note: This software update includes the optimize battery management software.
The customer installable software will allow customers’ biomedical engineer or equivalent to implement the FCO without having to wait for a Philips FSE or qualified service personnel to implement.
The primary strategy for the Pulse Rate software update is installation by the customer
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