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

Model Number 866389

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2024

Event Type  Death  

Manufacturer Narrative

Configuration information was provided to biomed to help with changes so the nurses in the future will not be allowed to silence alarms at the central.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.(b)(6).

Event Description

It was reported the nurse silenced an ecg leads off red inop alarm but did not go to the room to check the patient, who was found deceased on the floor with ecg leads off.The customer's configuration was set to not allow nurses to silence parameter red alarms at the pic ix; however, the ecg leads off inop red alarm could still be silenced.The customer has now requested to extend this configuration to the red inop alarms as well so none can be silenced at the central station.

Manufacturer Narrative

Philips received a complaint on the patient information center ix indicating that the nurse silenced an ecg leads off red inop alarm but did not go to the room to check the patient, who was found deceased on the floor with ecg leads off.It is known that the device was in use at the time of the event.The following communications were performed: a good faith effort (gfe) was made to obtain additional information on the reported issue and additional review of the information confirmed that the configuration of the pic ix did not allow silencing of red measurement parameter alarms but still allowed silencing of red inops.When philips clinical specialist onsite was reviewing the configuration with the biomed, it was noted nurses continued to silence the red inops from the central station, but did not go to the bedside; therefore, the customer had requested a change to the configuration to allow no silencing of any red alarm at the pic ix.A philips remote service engineer (rse) provided configuration information to the biomed to help with changes so the nurses in the future would not be allowed to silence alarms at the central.Based on this information, the pic ix performed as configured and designed and did not cause or contribute to the reported death; however, it was also noted the nurses continued to silence the red inop alarms leading up to the patient event, so clinical workflow and alarm management were factors in the event, which were use related.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.A clinical harm review was performed and indicated that this event is assessed as not related to the device in this case.Analysis was performed and investigation has been completed.The pic ix performed as configured and designed and did not cause or contribute to the reported death; however, clinical workflow and alarm management were factors in the event, which were use related.

• 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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19203620
• MDR Text Key: 341292194
• Report Number: 1218950-2024-00304
• 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: K183387
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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