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

Model Number 866389

Device Problem False Alarm (1013)

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

Event Date 04/15/2024

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted after the device has been received by philips for evaluation.E1: reporting institution phone#:(b)(6).E1: reporter phone# (b)(6).

Event Description

It was reported at the patient information center ix red alarm rings in yellow.Patient involvement is unknown.There was no report of patient or user harm.

Manufacturer Narrative

During investigation the reported problem turned out to be not reportable analysis was performed and investigation has been completed.Based on the analysis, there was no malfunction in pic ix because alarm did not generate due to the configuration of the mx400.The pic ix system was working as intended.A philips remote service engineer (rse) spoke with the customer and identified that a second case was opened for the mx400 bedside monitor.The reported issue with the monitor represented a no malfunction.

Event Description

It was reported at the patient information center ix red alarm rings in yellow.It is known that the device was in use at the time of the event.No adverse event occurred.

• 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: 19162760
• MDR Text Key: 341120793
• Report Number: 1218950-2024-00287
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: 00884838104594
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K211900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• 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
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/23/2024
• 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