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

Model Number 865351

Device Problem Defective Alarm (1014)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.During a call with the customer regarding this event, the customer reported they put a new battery in the mx40 device and it connected to the piic ix.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.

Event Description

The customer reported the patient had to be resuscitated (b)(6) 2020 at approximately 01:00 pm.The nurse was in the patient's room when the event occurred.The customer reported the mx40 was not working at the time of the event and the users were unable to find data for the incident in the patient information center (piic ix).The patient was transferred to the icu.

Manufacturer Narrative

H10:a philips remote service engineer (rse) talked to the customer in order to troubleshoot the issue.The rse confirmed the reported issue and found that it had occurred due to the mx40's battery levels.The mx40 had died which resulted in no data being sent to the pic ix.The product support engineer (pse) reviewed the logs and confirmed there were no alarms during the timeframe of the incident in the audit logs because the mx40 had been offline since 10:59 am.(b)(6) 2020 at 00:34:51 there was an inop, tele-battery: maintenance generated at 00:34:50.This inop is generated when the mx40 rechargeable liion battery has exceeded 500 complete charge/discharge cycles.This also correlates to the boot up information from the device debug log that shows the battery voltage at 3997mv (3997 millivolts or 3.9volts).This indicates reduced capacity of the battery.The mx40 connection to the pic was lost at 10:59:05 on 18dec2020.Upon replacement of the battery, the device booted up and established connection with the pic at 15:14:32 on 18dec2020.There was no malfunction of the mx40 telemetry device.The device remains in use at the customer's site and no subsequent calls have been received regarding this issue.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: 11074013
• MDR Text Key: 223705527
• Report Number: 1218950-2020-08088
• 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: 12/18/2020

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: 12/18/2020
• Initial Date FDA Received: 12/27/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening