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

Model Number 866389

Device Problem Defective Alarm (1014)

Patient Problem Asystole (4442)

Event Date 03/16/2024

Event Type  Death  

Event Description

It was reported the patient passed away while being monitored.The alarm was received at the central station but the user was unable to view the alarm conditions in the clinical audit trail; therefore, the customer requested assistance pulling logs and investigating the incident.

Manufacturer Narrative

The complaint was escalated for technical investigation.A product support engineer (pse) reviewed the clinical audit log, and the log shows that on (b)(6) 2024, at 08:06:05, an asystole alarm was generated.The asystole alarm was then acknowledged by the user at the central at 08:08:51.Then, the system generated several reminders every three minutes, as the condition was still present.At 08:26:23, the asystole alarm ended.Based on the information available, there was no product malfunction found with the device, as the device alarmed for asystole and was acknowledged by the user, and the device reminded for this red alarm.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 19124912
• MDR Text Key: 340382358
• Report Number: 9610816-2024-00198
• 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: Other Health Care Professional
• Type of Report: Initial

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: 866389
• Device Catalogue Number: 866060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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