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

Model Number 866389

Device Problem Defective Alarm (1014)

Patient Problem Ventricular Fibrillation (2130)

Event Date 03/09/2024

Event Type  Death  

Manufacturer Narrative

Reporting institution phone # (b)(6).Reporter phone # (b)(6).Involved x3 is handled within mfr report number: 9610816-2024-00158 a follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported while monitoring in the emergency department, the patient went into asystole and it was alleged no alarms were generated by the device.The patient subsequently passed away with the official cause of death determined to be ventricular fibrillation.It was indicated the x3 monitor and the pic ix central station were online during this time and providing alarms at both devices; however, the nurses indicated there was no alarm heard.

Manufacturer Narrative

A field service engineer went onsite to evaluate the reported issue.Based on the information provided the pic ix performed as specified when tested to generate alarms.Alarms are logged in the clinical audit log which were acknowledged at the bedside and at the pic ix.The fse noticed the sounding of alarms at the pic ix was almost inaudible and deactivated the display's internal speaker and activated the philips speaker attached to the pic ix.The field service engineer who did the installation confirmed that during the installation of the central station, the official philips speaker was installed and functional.Based on the information available, the reported issue was caused by a wrong configuration of the speaker, as the displays internal speaker was used, instead of the philips speaker attached to the pic ix.Therefore the sound was almost inaudible.The reported issue does not represent a malfunction of the device, but is related to a user / configuration issue instead.

Event Description

It was reported while monitoring in the emergency department, the patient went into asystole and it was alleged no alarms were generated by the device.The patient subsequently passed away with the official cause of death determined to be ventricular fibrillation.It was indicated the x3 monitor and the pic ix central station were online during this time and providing alarms at both devices; however, the nurses indicated there was no alarm heard.

• 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: 18957397
• MDR Text Key: 338301758
• Report Number: 1218950-2024-00210
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K183387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 03/13/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2020
• 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