MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PIC IX HARDWARE

Model Number 866424

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

Patient Problem Aneurysm (1708)

Event Date 09/04/2021

Event Type  Death  

Event Description

The customer reported that a patient passed away while connected to a philips device.The customer specified that the device did not contribute to the event.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that a patient passed away while connected to a philips device.The customer specified that the device did not contribute to the event.

Manufacturer Narrative

Philips remote service engineer (rse) pulled the audit logs and provided them to the customer.The audit logs confirmed that the philips equipment was alarming appropriately.There was no malfunction of the philips device.The customer was requesting help with pulling audit logs only.Once the audit logs were pulled the customer confirmed that no issue was present.The case was subsequently closed.

• Brand Name: PIC IX HARDWARE
• Type of Device: PIC IX HARDWARE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13087368
• MDR Text Key: 282771123
• Report Number: 1218950-2021-11206
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102495
• 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?: No
• 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: 12/21/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 02/16/2022
• 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): Death
• Patient Age: 72 YR
• Patient Sex: Male