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

Model Number 866389

Device Problem No Audible Alarm (1019)

Patient Problems Bradycardia (1751); Asystole (4442); Insufficient Information (4580)

Event Date 02/22/2024

Event Type  Death  

Manufacturer Narrative

Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.Reporting institution phone: (b)(6).Reporter phone: (b)(6).

Event Description

It was reported the system did not recognize a patient event as a red alarm.The patient deteriorted with asystole and bradycardia.The device was in clinical use.An adverse event was reported.The patient expired.

Manufacturer Narrative

A philips clinical specialist & product support engineer has reviewed the audit logs, which identified the patient had an active asystole alarm from asistolia generada a las 09:57:58 and continued until the ecg leads off generated at 10:43:34 (this is a red level inop as well).The pic was playing a red sound from 09:23:21 onward.The audit log also identified many cannot analyze ecg alarms at 10:24:55, 10:25:51, 10:28:46, 10:29:21, 10:29:31, 10:29:34 during the time in question which may decrease the effectiveness of arrhythmia monitoring.This is described in the st/ar application note: during this inop/technical condition, the arrhythmia analysis continues and an alarm will be announced if an alarm condition is met.Since the cannot analyze ecg inop/technical alarm indicates that the effectiveness of the arrhythmia monitoring for the patient is compromised, a quick response to this alarm is important.Multiple instances are also seen where the staff interacted with the pic to capture the 12 lead several different times, but no one acknowledged the asystole alarm from 09:57:58.The asystole alarm ended at 11:11:07 when the device was no longer connected to the pic ix.Based on the information provided to philips, it was determined that there was no product malfunction, and the device was functioning as intended.There was an active asystole alarm from 09:57:58, there was no further alarm at 10:23:34.The cause of the reported problem was an active asystole alarm that was not acknowledged.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: 18799093
• MDR Text Key: 336459910
• Report Number: 1218950-2024-00142
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Nurse
• 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: 02/23/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2018
• 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
• Patient Age: 63 YR
• Patient Sex: Male