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

Model Number 866389

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cardiac Arrest (1762)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

The philips field service engineer (fse) went onsite and analyzed the piic monitoring central.Through the clinical log, the fse determined that the central station sounded the "xbradi 51<55" alarm at 10:24:43 am right after the "asystole" alarm generated at 10:24:52 am.The alarm was manually silenced by a user using the monitor at 10:26 am.The fse found the spo2 parameter had a saturation alarm deactivated in the monitor.The central station's clinical audit log showed that the spo2 alarm was deactivated by the user directly on the(b)(6) 2023 at 07:09 pm.The fse carried out sound and visual alarm tests on the monitor and the monitoring and no anomaly in its software or hardware was diagnosed.The central station was 100% functional.Based on the information available and the testing conducted, the cause of the reported problem was user, as the user silenced the alarms.The reported problem was confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

Philips received a complaint on the patient information center ix indicating that there was an adverse event, where a patient experienced cardiac arrest on (b)(6) 2023 around 10:30 am.The patient was resuscitated, and his vital signs were stable.

• 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: 16940230
• MDR Text Key: 315311453
• Report Number: 1218950-2023-00333
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/16/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male