MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIC IX HARDWARE

Model Number 866424

Device Problems Defective Alarm (1014); Unintended Electrical Shock (4018)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2023

Event Type  Death  

Event Description

The customer reported the patient was shocked by a bedside monitor.The patient died.

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.Reporter phone #: (b)(6).Reporting address state: (b)(6).

Event Description

The customer reported the device alarmed with yellow alarm instead of an expected red alarm.There was no patient harm reported.

Manufacturer Narrative

The field service engineer went on customer site to collect the audit log files.The following functional tests were performed: ¿ logs from the pic ix were obtained.¿ logs have been analyzed by the pse.Results of functional testing indicate there is no malfunction on the pic ix.The audit logs showed there was a red alarm generated for vent fib/tach at 01:36:12 on both the mamh03sp05ipcu and mamhllop06tele hosts (in blue and red).The red alarm kept ringing on host mamh03sp05ipcu until 01:45:55 where it ended.The yellow alarm was generated for the pvc until it was ended at 01:46:37.Overall, there was a red alarm that was sounded until 01:45:55 and then it was turned off, then the yellow alarm went on.After it was turned off (could either have been silenced or that the vtach then did not fit the criteria of having the alarm go red), the user likely saw that yellow alarm relating to the pvc on that host 05ipcu host.The next red alarm occurred on (b)(6), 2023, and 05:01:01 over 3 hours later.Unless there is a reason why this patient should have been red alarmed between 01:45:55 and 05:01:01, the pse does not see any problems with the alarms.Based on the information available and the testing conducted, the device was functioning as intended and there is no malfunction on the device the device was confirmed to be operating per specifications and no failure was identified.

Event Description

Philips received a complaint on the pic ix hardware questioning whether a yellow alarm should have been a red alarm.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: PIC IX HARDWARE
• Type of Device: PIC IX HARDWARE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; b1-3/d6; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; b1-3/d6; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; b1-3/d6; andover, MA 01810 ; 6172455900
• MDR Report Key: 16377826
• MDR Text Key: 309550964
• Report Number: 9610816-2023-00078
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,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: 866424
• Device Catalogue Number: 866424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/08/2023; 03/21/2023
• Supplement Dates FDA Received: 03/27/2023; 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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