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

Model Number 866389

Device Problems Use of Incorrect Control/Treatment Settings (1126); Insufficient Information (3190)

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

Event Date 10/02/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the philips intellivue system did not alarm when patient condition criteria was met.The device was in use on a patient.There was no report of patient or user harm.

Event Description

The customer reported that the philips intellivue patient information center ix system did not alarm for an arrhythmia alarm when it was noticed by the monitor technician that an arrhythmia was occurring.The device was in use on a patient.There was no report of patient or user harm.The clinical audit logs from the pic ix were obtained and reviewed by a clinical solutions implementation consultant.The audit logs showed the action of the ecg alarms being turned off by the user.Based on the information available and the testing conducted, the cause of the reported problem was caused by a user error.The ecg alarms were turned off.The reported problem was not confirmed.The device was working as configured at the time.Based on the information available and results of additional analysis further action has been initiated.The clinical solutions implementation consultant reviewed all monitor configurations from the site and all the monitors that had the ability to have the ecg alarms turned off were reconfigured.The device was operational after repairs (reconfiguration) was completed.

• 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: 15673664
• MDR Text Key: 302527127
• Report Number: 1218950-2022-00943
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• 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?: Yes
• Date Manufacturer Received: 01/05/2023
• 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