MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX500 PATIENT MONITOR

Model Number 866064

Device Problems Defective Alarm (1014); No Audible Alarm (1019)

Patient Problem Bradycardia (1751)

Event Date 10/03/2023

Event Type  Death  

Event Description

It was reported on (b)(6) 2023, there was a failure to alarm for bradycardia at the central station and the bedside monitor.The device was in use and the monitor displayed a heart rate of 54 bpm, which was outside the set parameters (high limit-200 bpm and low limit-100 bpm).It was indicated the bradycardia was not managed in time.

Manufacturer Narrative

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.

Manufacturer Narrative

The alleged time of the event was between 12:30 and 15:30 hours and new information was provided that the event resulted in the patient death.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.The clinical audit logs also indicate that there were alarms for exceeding the low hr limit.Based on the information available and the testing conducted, the device was functioning as intended and there was no trouble found with the device.The reported problem was not confirmed.Corrected information: outcomes attributed to ae is updated to death, 510k: k131872, a4 patient weight: 4 kg, f3: user facility: (b)(4), d1: intellivue mx500 patient monitor, h1 type of reported complaint is updated to death, d2a: intellivue mx500 patient monitor, d4: model#: 866064, d4 catalog#: 866064, d4 serial#: (b)(6), d4 unique identifier: (b)(4).

• Brand Name: INTELLIVUE MX500 PATIENT MONITOR
• Type of Device: INTELLIVUE MX500 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18260511
• MDR Text Key: 329638598
• Report Number: 9610816-2023-00642
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131872
• 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: 866064
• Device Catalogue Number: 866064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• 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; Life Threatening
• Patient Weight: 4 KG