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

Model Number 866389

Device Problem Alarm Not Visible (1022)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817)

Event Date 11/17/2022

Event Type  Death  

Manufacturer Narrative

Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.Fda procode updated based on information known at this time.Catalog item id and 510k is unknown at time of report.

Event Description

After a code blue a patient died.Looking back through the patient data after they noticed ecg changes.The customer has st monitoring on and alarms off.Ste monitoring is also on with alarms on as well.After reviewing strips they reported there was st elevation, and there were many pvc alarms throughout the day but no ste alarms.The customer reported the possibility of ste alarms not generating (b)(6), and the audit log would be investigated.Audit log was reviewed on (b)(6) after customer reported this patient had died.

Event Description

The customer reported that the ste alarms was not generate from the device.A patient¿s death was reported, the device was in use at the time of the event.A field service engineer and the clinical solutions implementation consultant went for onsite service and obtained the audit log file and the relevant ecg stripes.The files were reviewed by the responsible product support engineer, and he stated that the conditions do not meet the alarming detection for the st alarms to have occurred.Therefore, the device was performing exactly as intended, no failure was identified.

Manufacturer Narrative

The field service engineer (fse) went for onsite service at the customer site and obtained the relevant log files.The product support engineer (pse) reviewed the provided logs and provided an analysis.The pse states that in order for an ste alarm to generate, the st portion of the ecg waveform must meet the elevation criteria.In this case the st portion of the waveform did not meet the criteria to trigger the ste alarm.The pse further elaborated the following information: the ste alarms will not alarm unless the st criteria has been met.For ste alarms to be announced, two or more contiguous st leads must exceed the defined set of lead limits.For st alarms to occur from the customer¿s data, both leads iii and augmented vector foot (avf) would need to be in violation.Single lead alarming only occurs if you are using a three-lead cable.For st alarms to occur from the customer¿s data, both leads iii and avf would need to be in violation.Based on the customer¿s data, and from what we highlighted before, only st-iii is in violation and not st-avf.Therefore, ste will not generate the alarm.Results of functional testing indicate that the device was working as designed.

Event Description

The customer indicating that st elevation (ste) alarms did not generate.The customer states that the ecg waveform strip did show an st elevation or "ste" had occurred in this case.The patient expired.

• 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: 15975352
• MDR Text Key: 305415773
• Report Number: 1218950-2022-01060
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: UNK283-PIIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 03/20/2023; 03/20/2023
• Supplement Dates FDA Received: 03/21/2023; 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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): Death
• Patient Sex: Female