MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Defective Alarm (1014)

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

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.Reporting institution phone (b)(6).Reporter phone (b)(6).

Event Description

The customer reported that they had a missed alarm.It is unknown if the device was in clinical use at the time the issue was discovered; there was no adverse event or patient harm reported.

Manufacturer Narrative

The missed vt alarm was registered between the timeframe of 14:15:09 ¿ 14:16:11.A philips remote service specialist (rss) indicated that the issue seemed to be related to dropouts during the mentioned times when the monitor had come off line for unknown reason, as the logs did not show any error during the time frame reported.The rss determined that the issue might have been that someone has moved the monitor and that created a bad connection with the network cable, as the alarms for ventricular tachycardia (vt) could be seen before and after this time period which indicates the measurement is working as intended.The rss advised the customer biomedical engineer (biomed) verify if an alarm was seen on the monitor during this time period or if the alarm was just left out on the philips information center ix (pic ix), then most likely due to lost connection.However, further investigations showed that the monitor has been offline/not connected during the reported event time.The rss spoke to the customer and recommended them checking with the ward, where it was.Concluded that the issue has not happened again.The customer will also check the measurement server link (msl) and network cables connected to the monitor to make sure this wasn't the reason for the event.The customer will contact philips and create a new case if issue were to happen again.Based on the information available and the testing conducted, the cause of the reported problem was a user error.The reported problem was confirmed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18417846
• MDR Text Key: 331580335
• Report Number: 1218950-2023-00977
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K211900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1