MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIBRIDGE ENTERPRISE

Model Number 866183

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2023

Event Type  Death  

Event Description

It was reported the customer did call in reporting that a patient had passed away harmed possibly due to the device.The customer was looking for an audit report.

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.

Manufacturer Narrative

Good faith effort (gfe) attempts were made to obtain additional details about the event, the outcome of any device evaluations, and potential causes of the alleged alarm failure.Due to insufficient information, the reported problem could not be confirmed.Due to insufficient information philips was unable to conduct functional analysis of the device if additional information is received the complaint file will be reopened.

• Brand Name: INTELLIBRIDGE ENTERPRISE
• Type of Device: INTELLIBRIDGE ENTERPRISE
• 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: 18370831
• MDR Text Key: 331046486
• Report Number: 1218950-2023-00962
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866183
• Device Catalogue Number: 866183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• 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