[175049254]
Situation: holter monitors are displaying "error code 602" when power is applied by either docking station or battery. This is unrecoverable error which render the device unusable. Background: spoke to a support rep with philips, he explained the issue that we are seeing is similar to the y2k issues where the date did not roll correctly. In our case, the year change from 2010 to 2020 did not happen on the holter monitors. Assessment: he has advised that there is currently "no workaround" and he does not have an eta for revolution. He stated that the philips r&d dept and engineering team is working on the issue and when a solution has been created, philips will be sending us a formal notification on how to resolve. We believe the resolution will be in the form of a firmware update which all the philips monitors will need to be updated. We are hoping this can be done as a server side push but worse case we will need to touch each one individually, which will require pulling back all the monitors and it working with clinical engineering to update firmware. We have asked for a daily status update so that we know how to plan for the work needing to be done and actual time to bring the system back up. Resolution: none at this time. Statement from philips: we want to bring to your attention an issue with the philips digitrak xt holter recorder (model 860322), philips has confirmed that - beginning on (b)(6) 2020 - if a battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display "error: 602" and fail to function further. At this time, there is no action that the user or philips service can take to clear this error. Philips has determined that an issue with the firmware results in an abnormal device behavior associated with the recorder's internal rest-time clock. This manifests itself when the year rolls over from 2019 to 2020. It affects all digitrak xt holter recorders, but no other philips system or device. Immediately upon learning of this issue at the beginning of (b)(6), philips began to work on a solution, dedicating both internal and external resources. That high priority effort continues. We will communicate with you as soon as a solution has been confirmed. By no later than friday, (b)(6), philips will provide an update and guidance. Regrettably, until then, your digitrak xt holter recorders cannot be restarted. Philips sincerely apologizes for the inconvenience this situation has caused. If you have any questions regarding this incident, please contact the customer care solution center at (b)(4). Inoperable monitors. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5