MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING

Model Number 865351

Device Problems Defective Alarm (1014); Alarm Not Visible (1022); Wireless Communication Problem (3283)

Patient Problems Death (1802); Loss of consciousness (2418)

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.The ccu staff also advised that they do not have someone watching the central station "24/7." the eme supervisor reviewed the information on the central and saw the station reported a "leads off" inop.The eme supervisor also tested the telemetry device and did not find a problem with it.The device was alarming as intended.However, the eme supervisor thinks if the telemetry was still on the patient as they say, then he would have expected another alarm other than the "leads off" inop.

Event Description

The hospital's eme supervisor reported that on (b)(6) 2021 at approximately 06:20 am a patient was found deceased.The ccu staff reported that the telemetry unit was still attached but they hadn't been made aware via the central station that there was a problem.

Manufacturer Narrative

Audit logs were provided by the customer via email; however, there was no information provided in the logs for the date of the incident referenced above.There was only information provided for (b)(6), 2020.A philips helpdesk engineer (he) requested the customer to pull the logs again; the logs were provided again via email; however there was no information provided in the logs for the date of the incident.Then he requested the extraction of logs from the mx40 itself.With the support tool provided by the he, the customer pulled logs from the mx40 and provided them via email.A philips engineer went to the site to pull the audit logs and mx40 logs using the support tool.A philips product support engineer (pse) reviewed the information provided in the audit logs and found that there was still no data for the date of the incident captured in the logs.The audit logs pulled by the philips engineer only provided data for (b)(6), 2021.The mx40 log captures device start up, speaker test at device start up, and any watchdog (software) events.The pse reviews this information in correlation with data from the audit log to draw conclusions about the performance of the mx40.Without the audit log data for the date in question, confirmation of alarms being sent from the mx40 to the piic is not possible.Based on our investigation, philips has insufficient information to make a determination on how the mx40 alarmed as alarms logs for the date and time of the incident were not available for review.The device remains at the customer site.The information was provided to the customer.

Event Description

The hospital's eme supervisor reported that on (b)(6), 2021 at approximately 06:20 am a patient was found deceased.The ccu staff reported that the telemetry unit was still attached but they hadn't been made aware via the central station that there was a problem.The ccu staff also advised that they do not have someone watching the central station "24/7." the eme supervisor reviewed the information on the central and saw the station reported a "leads off" inop.The eme supervisor also tested the telemetry device and did not find a problem with it; it was alarming as intended.However, the eme supervisor thinks if the telemetry was still on the patient as they say, then he would have expected another alarm other than the "leads off" inop.

• Brand Name: MX40 2.4 GHZ SMART HOPPING
• Type of Device: MX40 2.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11155514
• MDR Text Key: 226285898
• Report Number: 1218950-2021-00208
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: 865351
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death