MAUDE Adverse Event Report: PHILIPS; MODULES MMS

Model Number MMS MODULES

Device Problems Radiofrequency Interference (RFI) (2314); Communication or Transmission Problem (2896)

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

Event Date 10/08/2015

Event Type  malfunction  

Event Description

The issue: the mx series monitors have a signal distortion effect on the ge ekg mac 5500 machine which could lead to a pt misdiagnosis or mistreated.The issue has been occurring when taking an ekg in close proximity to a bedside monitor with the leads attached to the bedside monitor.It was an intermittent issue that we were able to duplicate but did not necessarily happen every time.The count which is affected: 53.The solution: philips believes that the problem is in the mms modules not the monitor itself.There were two solutions introduced by them; the first is a temporary one which will require installation of the old mms in all monitors.The second solution is sending the new mms to (b)(6) to be redesigned, rebuilt to fix the problem permanently.The temporary solution steps which were taken: the new mms modules were removed and the old mms were installed by our biomed.Our biomed and the clinical staff had tested the old mms interactivity on ge ecg machines in er's to verify if the solution is working.The mac 5500 was moved as close as possible to bedside monitors no ecg's machine distortions as result of interference from philips monitors were found.The permanent solution: we still have the 53 new modules which should be shipped to (b)(6) as per philips, and we didn't get a word from philips yet about them.It is a brand new philips system, was installed in the emergency department on (b)(6) 2015.The issue was discovered on (b)(6) 2015.The old modules were installed and tested on (b)(6) 2015.

• Type of Device: MODULES MMS
• Manufacturer (Section D): PHILIPS; manhasset NY 11030
• MDR Report Key: 5327188
• MDR Text Key: 34440195
• Report Number: MW5058725
• Device Sequence Number: 2
• Product Code: DRG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MMS MODULES
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other