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

Model Number 865350

Device Problems No Audible Alarm (1019); Audible Prompt/Feedback Problem (4020)

Patient Problems Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2024

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

This record was reviewed due to the customer requesting log review for device events leading up to a patient event around 22:35.They report that review of the associated picix shows the monitor was put in ¿standby mode¿ and also showed that monitoring resumed approximately 3.5hrs thereafter.Ecg displayed asystole when monitoring resumed.Upon asystole display, artifact was also seen for at least an hour, which is thought to be from medical intervention such as cpr compressions.The customer is unsure whether the lack of monitoring was associated with human error vs device malfunction, although the record also states the monitor cable was unplugged.Of note, it is assumed that the patient expired based on log review, although death was not yet confirmed by the hospital.No other clinical information or medical intervention was reported.The root cause of the reported event remains unknown at this time and gfe attempts will be initiated.

Manufacturer Narrative

A review of the data warehouse data from the pic ix showed the monitor was place in "standby" mode prior to event.Data review showed the monitoring resumed 3.5 hr later, with ecg rhythm asystole.The nurse manager stated this is likely a human error vs.Monitor malfunction.The logs provided were reviewed by a philips clinical specialist and the investigation showed that the mx40 was put into standby, when the mx40 was on it alarmed as expected.This should be considered use error as the products was working as configured within the design of the product.The reported event of patient death was reviewed by pms clinical expert.This event is assessed as related to use error or inherent use of the device.Log review revealed the user placed the mx40 in standby mode; however, the sequence of events leading to this action remains unknown.Further, this event is assessed as labeled and predicted in the risk management document under risk id hu-36, with a hazard indicating the device does not monitor or alarm for the duration of standby state, resulting in the loss/delay of monitoring.A review of the logs indicated the mx40 was placed in standby when attached to the patient; therefore, there were no waveforms at the pic ix and no monitoring available for the patient.Based on this information, the mx40 behaved as designed and did not cause or contribute to the patient death; however, the device being placed in standby was a use error, which likely was a factor in the event.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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19137129
• MDR Text Key: 340525301
• Report Number: 1218950-2024-00272
• 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
• Reporter Occupation: Other Health Care Professional
• 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?: No
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2019
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 73 KG