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

Model Number 866424

Device Problem Alarm Not Visible (1022)

Patient Problem Insufficient Information (4580)

Event Date 05/13/2022

Event Type  Death  

Event Description

The customer reported that the intellivue mx40 did not give an alarm between 13:00 and 14:00 and because they did not see an alarm the patient passed away.The time of death was on (b)(6) 2022, around 14:00.A good faith effort (gfe) confirmed that the (pic ix teledw-cp1) didn't provide alarms because the mx40 was disconnected at that time.A philips field service engineer (fse) went to the customer site.A gfe confirmed that the log files from the (pic ix teledw-cp1) showed the mx40 went offline at 13:04:35 and went online again on 14:28:26.In this time period the mx40 did not have a connection and was functioning as a standalone monitor.The fse also stated that the piic ix was tested and it is working as intended.Pic ix logs were requested, but no response was provided.It is unknown if the device went offline intentionally, if the staff put the device on standby or if this was an unplanned lost connection.It is unclear if the lack of alarm may have been in a factor in the subsequent death of the patient.It remains unclear if the lack of alarms was the result of failure, malfunction, improper or inadequate design, manufacture, labeling, or user error.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15731586
• MDR Text Key: 303045724
• Report Number: 1218950-2022-00954
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113125
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• 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