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

Model Number 865350

Device Problems Alarm Not Visible (1022); Signal Artifact/Noise (1036)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 11/03/2020

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that on (b)(6) 2020 at 11:45 am, a patient coded and the device did not alarm.The code resulted in patient death.The customer stated there was an artifact on 2 & 3 but they didn't check any other lead sets.The device was removed from service by the biomed.

Manufacturer Narrative

A philips field service engineer (fse) provided the alarm audit log, the rfda log ,and device debug log from the hospital site.The fse also inspected the device while at the hospital site.The fse was provided a 10 second capture of the electrocardiograph report (strip) by the hospital.Our philips product support engineer (pse) reviewed the alarm audit log, rfda log, device debug log, and strip.Philips determined the mx40 alarmed appropriately as the alarm logs for the date and time of the incident shows heart rate related alarms and alarms being acknowledged.This investigation was provided to the customer.The device remains at the hospital 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 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10844065
• MDR Text Key: 216375207
• Report Number: 1218950-2020-06892
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death