EBME Forums Forums Maintenance Technical Assistance Philips HeartStart XL - M4735A

Did the device bring up an error code in the error log after exhibiting this fault? we have never had a fault with the opto joule switch...yet, but in the past have had problems with the pacer keypad not working and passing the daily check. This didnt leave an error code in the error log either. Given the limitations of the current self-test sequence on this device, our concerns are that it is not made sufficiently clear to the users that the this self-test does not verify functionality completely. After all the member of clinical staff that undertakes the daily shift check would consider the defib ready for use in an emergency if the test strip tells them it has passed all tests, when in fact it is faulty. We have expressed our concerns to Philips with regards to this device not picking up internal faults and had an unsatisfatory response..(again). My advice is to report this matter to the MHRA as Mr Ling says and let them add it to their surveillance database.

The MHRA have been informed in detail.
My only concern is that their primary course of action appears to be to go to the manufacturer (Philips) and see if they have had any other occurences of this fault / failure.
This does rely heavily on Philips own monitoring processes (and desire to hold their hands up to a design failure) which is a serious flaw in the MHRA methodology. In our case the Philips engineer was not aware of any kind of reporting process, and didn't really seem interested when pressed on the issue; saying (rather lamely) the information on the failure would be picked up from the Service Report.
It wasn't.
The final report wasn't detailed enough (same engineer).
Philips could only ever possibly tell the MHRA how many of this part had been supplied - but the serious consequences of the fault would never be highlighted without the intervention of a conscientious Biomed / Clinical Technolgist (or Philips engineer).

U P D A T E (Nov06)

The MHRA have revealed that there has been at least one other instance of near identical faults with these defibrillators reported to them where energy was set to one level and the unit delivered something different than on the tin. Despite passing daily checks.