MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS DIGITRAK XT HOLTER SYSTEM; ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS

Model Number 860332

Device Problems Use of Device Problem (1670); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2019

Event Type  No Answer Provided  

Event Description

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 cases, the year change from 2010 to 2020 did not happen properly on the holter monitors.Assessment: he has advised that there is currently ¿no workaround¿ and he does not have and eta for resolution.He stated that the philips r and 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 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 abdominal device behavior associated with the recorder¿s internal real-time clock.This manifests itself when the year rolls over from 2019-2020.It affects all digitrak xt holter recorder, but no other philips system or device.Immediately upon learning upon learning of this issue at the beginning of january, philips began to work on solution, dedicating both internal philips 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)(6).Fda safety report id # (b)(4).

• Brand Name: PHILIPS DIGITRAK XT HOLTER SYSTEM
• Type of Device: ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS
• MDR Report Key: 9569791
• MDR Text Key: 174672305
• Report Number: MW5092134
• Device Sequence Number: 1
• Product Code: MWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 860332
• Device Catalogue Number: 860332
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1