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

Model Number 866389

Device Problem Delayed Alarm (1011)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported a delay with the alarm sound.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

Per the clinical audit trail , the event occurred in central monitoring unit (cmu) on hosts: ph1_telsurv07 (primary surveillance) sounded at 10/09/23, 09:02:11/mil7gn_surv01 (ovv) 09:02:16 for rm #7gn421b.The clinical support specialist explained to the customer regarding questions about needing documentation on the length, if any, delay for an alarm to sound at the picix surveillance to the overview (ovv).The css explained, there is no documentation in the ifu about this issue and would provide any input the bu product specialist gives concerning the issue.Based on the information available and the testing conducted, the reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The customer was advised that the ifu does not specify the delay for an alarm to sound at the pic surveillance to the overview.However, the customer will be contacted with any further input received from the business unit product specialist.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: 18031054
• MDR Text Key: 326866590
• Report Number: 1218950-2023-00826
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• 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?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/27/2023
• 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