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

Model Number 865351

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 04/12/2018

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Patient info has been requested serial number not provided at time of report (b)(6).

Event Description

The customer reported that the mx40 telemetry device failed to provide an alarm to alert the staff of the change in the patient condition.The customer stated the involved patient died while the central monitor's display did not display any alarms because the mx40's battery was depleted, causing the device to power to be off while monitoring a patient.

Manufacturer Narrative

H3 and h6: based on the information provided the device functioned as intended, the battery inop yellow alarm alerted at the piic (philips intellivue information center).The customer did not change the batteries as they were notified to do, which resulted in the mx40 powering off.This event was due to user error, there is no indication of a device malfunction.The fse (field service engineer) was dispatched to change the alarm setting from yellow to red per the customer's request.It the fse went onsite on 13apr2018 and changed the alarm settings per the customer's request.The device remains at the customer's site.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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: 7444182
• MDR Text Key: 105952307
• Report Number: 1218950-2018-03543
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

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: 865351
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 92 YR