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

Model Number 866389

Device Problem Defective Alarm (1014)

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

Event Date 10/03/2023

Event Type  Death  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported that the system did not alarm.The device was in use.The patient died.

Manufacturer Narrative

The complaint was escalated for technical investigation, and the clinical audit logs show that the last hr alarm (**hr 206>200) was generated at 15:13:03 and terminated a few seconds later.After that, there were several inops related to ecg / respiratory lead off, which may indicate poor electrode contact to the skin.Noisy ecg was also shown in the logs, which means that ecg could not be analyzed.From 15:13 until 17:39, there were no ecg related alerts in the clinical audit trail.Based on the information available and the testing conducted, the device was functioning as intended and there was no trouble found with the device.A clinical harm review was performed, and this event is assessed as not related to the device in this case.The reported problem was not confirmed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

Philips received a complaint on the patient information center ix indicating that on (b)(6) 2023, between 12:30 and 15:30, the central scope alarm, and the patient alarm did not sound.The customer reported that the scope displayed a heart rate below the norm (hr = 54), and the baby's scope alarms had a high limit of 200 and a low limit of 100.Bradycardia was not managed in time, and the patient died.A good faith effort (gfe) was performed, and it was provided that the customer advised that the death was not the result of a malfunction of the device.The cause of death remains unknown.

• 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: 18068352
• MDR Text Key: 327321934
• Report Number: 1218950-2023-00820
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: RE
• 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: 10/16/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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
• Patient Weight: 4 KG