MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Device Alarm System (1012)

Patient Problem Asystole (4442)

Event Date 03/16/2023

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.

Event Description

The customer reported that the mx40 did not alarm for a vfib or asystole event for a patient.The device was in use monitoring a patient at the time of the reported event.The patient died.

Manufacturer Narrative

This report is based on information provided by philips remote clinical support and a field service engineer (fse).Philips received a complaint that the mx40 1.4 ghz smart hopping device did not alarm for a vtach/ vfib and an asystole on (b)(6) 2023 and the patient passed away.The device was in clinical use during the event.The central station pic ix logs were pulled and reviewed by a philips support engineer.The pic ix logs indicated that alarms for vtach and asystole were being generated throughout the event time frame and vfib/vtach alarms were silenced by the user at 15:15.There were also technical inop alarms for ecg leads off and cannot analyze ecg provided during the time in question based on the information available and the testing conducted, the device was functioning as intended and there is no malfunction on the device.The reported problem was not confirmed and there is no indication that the device caused or contributed to the reported event.The device was confirmed to be operating per specifications and no failure was identified.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: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• 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: 16760964
• MDR Text Key: 313492195
• Report Number: 1218950-2023-00230
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Date Device Manufactured: 09/18/2015
• 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