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 03/23/2024

Event Type  malfunction  

Event Description

It was reported that there was a delay with the extrem pressure (art) alarms.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

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

Event Description

It was reported that there was a delay with the extreme pressure (art) alarms.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

A remote service engineer (rse) spoke to the biomedical engineer (biomed), who reported that there was a delay with the extreme pressure (art) alarms.A good faith effort (gfe) was made to obtain additional information about the reported issue but the efforts were unsuccessful.Based on the information available, the exact cause of the reported issue could not be established.

• 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: 19113845
• MDR Text Key: 340233850
• Report Number: 1218950-2024-00260
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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: 03/23/2024
• Initial Date FDA Received: 04/16/2024
• Date Device Manufactured: 06/08/2016
• 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