MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX750 PATIENT MONITOR

Model Number 866471

Device Problem Defective Alarm (1014)

Patient Problem Asystole (4442)

Event Date 10/26/2023

Event Type  Death  

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.E1: reporter institution phone number (b)(6).E1: reporter phone number (b)(6).

Event Description

It was reported that on (b)(6) 2023, at around 7:30 p.M., an isolated patient with covid pneumonia (with a fixed therapy limitation without intubation/resuscitation) was found deceased in the intensive care unit.The staff on duty state that the monitor did not detect the asystole and that there was no alarm message via the central monitoring from the monitor at the bedside.

Manufacturer Narrative

A philips field service engineer (fse) visited the customer site to evaluate the alleged malfunctioning devices, collect logs, and clinical audit trails.Results of functional tests, mtk (metrological controls), stk (safety control checks) and metrological inspection according to mpbetriebv, confirmed that both x3 and mx-750 devices were working per specification.Furthermore, the fse confirmed that electrocardiogram (ecg) from alarm has been reconfigured from blue technical alarm to yellow alarm and the alarm source has been changed from ecg to "auto".A philips product support engineer (pse) and a philips clinical specialist (cs) evaluated the following documents: workflow, audit log (entire ¿ unfiltered ¿ unit ¿ seven days of data), configuration file for host and companion monitors, device log from host/companion/mms monitors, alarm review from pic ix and ivpm, rhythm strips and technical logs.Analysis results revealed that the arrhythmia was off, respiratory alarms were off, spo2 limits were wide and that the electrocardiogram (ecg) leads were noted to be off as well.The monitor is set for split latching.When the x3 (set for red/yellow latching) is connected to the monitor that the monitor determines the alarm settings.Based on the information available and the testing conducted confirming that alarm for arrhythmia was off, respiratory alarms were off, spo2 limits were wide and that the electrocardiogram (ecg) leads were noted to be off as well.In addition, it was indicated that the asystole was not detected because one or more leads were off, though the monitor provided an inop alarm for ecg off, users did not respond to the inop and due to the lack of alarm, there was a delay in care to the patient.Due to aforementioned information, it appears the device function did not cause or contribute to the reported event; however, alarm management or user response to inops may have been a factor.The reported problem was not confirmed.

• Brand Name: INTELLIVUE MX750 PATIENT MONITOR
• Type of Device: INTELLIVUE MX750 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: 18176259
• MDR Text Key: 328609856
• Report Number: 9610816-2023-00599
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838083332
• UDI-Public: 00884838083332
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K210906
• 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: 866471
• Device Catalogue Number: 866471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 68 KG