MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PHILIPS INTELLIVUE X3; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number INTELLIVUE X3

Device Problems Computer Software Problem (1112); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2022

Event Type  malfunction  

Event Description

Patient a was being monitored in room on an x3 monitor attached to an mx800.Parameters being monitored were ecg, oxygen saturation, and non-invasive blood pressure.The charge nurse at the central station just happened to look over and note that patient a's segment was showing an arterial line wave form.Puzzled the charge nurse verified there was no arterial line even attached to the x3 and called biomed.When biomed arrived, the condition had cleared but the staff had taken a picture as proof.Biomed was unable to duplicate a problem but called philips for an on-site service visit for further troubleshooting.The philips rep arrived and proceeded to review error codes and logs, nothing appeared amiss.After a time as the philips rep and biomed were discussing what they had seen and what had been done it was noted that the log was showing activity for the aforementioned x3 that neither biomed nor philips had performed.As luck would have it as we were reviewing these items the x3 showed being disconnected but the waveforms and labels continued to be displayed on the central.A quick survey of the floor found that only 1 x3 had just been disconnected.This unit was obtained by the biomed tech, and it was observed that the device name was the same as the original x3.Long story short, somehow the philips system had allowed 2 devices with the same device name to be active at the same time and occasionally sharing data.The device name was changed, and the problem was corrected.Manufacturer response for x3 monitor, philips (per site reporter).Manufacturer rep cleared problem and returned device to service.Manufacturer response for x3 patient monitor, philips (per site reporter).This was the second device that was sharing data.The philips rep changed the device name to verify that there and verified there was no longer sharing.

• Brand Name: PHILIPS INTELLIVUE X3
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; 3000 minuteman road; mail stop 4202; andover MA 01810
• MDR Report Key: 14073552
• MDR Text Key: 288990516
• Report Number: 14073552
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/14/2022

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?: Yes
• Device Model Number: INTELLIVUE X3
• Device Catalogue Number: 867030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2022
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male