MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 2.4 GHZ SMART HOPPING

Model Number 865351

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Bradycardia (1751)

Event Date 10/30/2022

Event Type  Death  

Event Description

It was reported the patient was placed on mx40 telemetry monitoring.The patient had been given a dnr (do not resuscitate).The patient came to the department for monitoring due to bradycardia, where the necessary drugs were prescribed.In the morning, the patient's leads (ecg) had become disconnected.During the morning examination, the patient was found to be deceased.Ecg rhythm does not require medication before the event.The patient monitoring system (mx40, its and pic ix) alarmed ecg leads off; however, the nursing staff didn't understand how to react to alarm properly.The information about the rhythm change did not reach the nursing staff until later.This occurred during night shift, when the ward had only two to three staff nurses present.It was stated that it was assumed that the patient's general condition was evaluated as not very serious.In regards to action taken to resolve the issue, the customer stated that they need to focus more on using the equipment and monitoring the equipment's alarms.

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.Reporting institution name: (b)(4).

Event Description

Philips received a complaint on the mx40 2.4 ghz smart hopping device indicating that the patient's leads (ecg) had become disconnected and the patient was found to be deceased.Technical investigation was performed and the results indicate that the telemetry device was operating as intended.The device was confirmed to be operating per specifications and no failure was identified.The customer was advised that the technical alarms of the patient monitoring system (such as leads off) should also be taken seriously as the patient's situation can progress to a dangerous situation during a technical alarm.The customer confirmed that the patient was connected to the mx40 patient monitor and the pic ix central monitor normally.The customer has also confirmed that they need to focus more on using the equipment and monitoring the equipment's alarms.The investigation concludes that no further action is required at this time.

• Brand Name: MX40 2.4 GHZ SMART HOPPING
• Type of Device: MX40 2.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15889496
• MDR Text Key: 304584022
• Report Number: 1218950-2022-01029
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K113125
• 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

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2018
• 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