MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIC IX HARDWARE

Model Number 866424

Device Problems Defective Alarm (1014); Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 09/30/2022

Event Type  Death  

Manufacturer Narrative

Reporting address state: (b)(6).Reporting institution phone: (b)(6).Reporter phone: (b)(6).Product info and 501k information is not available at time of report.A follow up report will be submitted after philips obtains more information concerning this event.

Event Description

Customer stated that the monitor did not alarm as expected.Patient had an aortic valve replacement and they were not able to resuscitate and patient died.

Event Description

The customer stated that the patient information center ix did not alarm as expected.The device was in use on a patient.There was a death reported.Results of functional testing indicate the piic was properly configured for the pacer alarms needed and showed no signs of misfunction or failure.The clinical audit logs showed the correct pacer alarms triggering both before and after for other patients within the unit.After discussion with clinical and the fse it was his understanding that using philips¿ documentation on what requires the alarm to be triggered (0.75x normal r-r value) and reviewing the patients alarm strips, the patient did not meet those minimum requirements.Hence no alarm.Based on the information available and the testing conducted, the cause of the reported problem was the ¿pacer not capturing¿ alarm was not triggered at the time of the patient in questions event.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.

• Brand Name: PIC IX HARDWARE
• Type of Device: PIC IX HARDWARE
• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15689796
• MDR Text Key: 302558356
• Report Number: 1218950-2022-00949
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866424
• Device Catalogue Number: 866424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/28/2022
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2020
• 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