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

Model Number 865350

Device Problems Battery Problem (2885); Unexpected Shutdown (4019)

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

Event Date 01/26/2021

Event Type  Death  

Manufacturer Narrative

A philips customer service clinical representative spoke with the customer.According to the audit log, multiple alarms for low sp02 and multiple alarms for low battery and then sp02 t off and then replace battery were sounded and acknowledged at the philips intellivue information center ix (piic ix) surveillance station.Then another notification that the device itself was off was found in the log.Per the ifu, spo2 measurement turns off when the inop appears and the display cannot be turned on once thetele batt low inop starts.If the screen was already on (device in monitoring mode or off network) then the screen dims when the battery is low.Per the telemetry service guide, telemetry battery safety warnings indicate "if you receive a tele battery low, tele battery empty, replace battery t, or tele battery temp alarm, the batteries must be promptly replaced.If these conditions are not corrected, they will result in a device shutdown and cessation of monitoring." the investigation indicates that the device was operating as expected.The investigation did not confirm a product malfunction.Good faith efforts were made to obtain additional information regarding whether the customer is alleging that the device contributed to the patient death, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.No further investigation or action is warranted at this time.

Event Description

The customer reported needing help with interpreting audit logs.The customer had a patient in bed 6b7-1 whose low battery alarm kept alarming.The mx40 then shut off sp02 to conserve battery power and then the mx40 shut down.When the staff went in to check in on the patient, the patient was unresponsive and died.

Manufacturer Narrative

Updated 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: 11344025
• MDR Text Key: 232403874
• Report Number: 1218950-2021-00879
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 865350
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1