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

Model Number 866389

Device Problem Power Problem (3010)

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

Event Date 03/22/2024

Event Type  malfunction  

Event Description

It was reported the uninterruptible power supply (ups) that power the central patient monitoring have failed across the hospital.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.

Manufacturer Narrative

Philips has issued a field safety notification which recommends that ups devices intended for operation in network and server rooms be kept in a temperature and humidity controlled environment, ensuring adequate airflow around the ups to prevent ups device failure.A field change order (fco) is in the process of being released.A philips representative will contact affected customers to schedule a visit from a philips field service engineer who will replace the malfunctioning ups.Based on the information available the cause of the reported problem was a failure of the 120v uninterruptable power supply.The reported problem was confirmed.Based on the information available and results of additional analysis further action has been initiated.The investigation concludes that no further action is required at this time.

• 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: 19126973
• MDR Text Key: 341128148
• Report Number: 1218950-2024-00268
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1