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

Model Number 866389

Device Problem Delayed Alarm (1011)

Patient Problem Tachycardia (2095)

Event Date 12/07/2023

Event Type  Death  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that on (b)(6) 2023 at 1604 hrs, on 7 blue west, rm #8743, there was a 15 second delay in the v-tach alarm.This resulted in a patient death.

Manufacturer Narrative

The remote service engineer (rse) spoke to the customer and determined that onsite service was required to pull configuration files and logs and perform a function check.However, the customer told the field service engineer (fse) that onsite service was no longer needed.A good faith effort (gfe) was performed to the customer to clarify the cause of death, to ask for configuration files and logs, and the cause of the issue, but no additional details were provided.The cause of the reported problem is unknown, as the customer has not responded to further requests about the issue.The reported problem was not confirmed.Due to the lack of available information, the exact cause for the reported issue remains unknown, and a malfunction of the device cannot be ruled out.The device remains in use at the customer site.

• 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: 18455347
• MDR Text Key: 332203037
• Report Number: 1218950-2024-00016
• 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: K153702
• 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,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: 866389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2018
• 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