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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING Back to Search Results
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.

 
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Brand NameMX40 1.4 GHZ SMART HOPPING
Type of DeviceMX40 1.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key11344025
MDR Text Key232403874
Report Number1218950-2021-00879
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 01/28/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/18/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number865350
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/28/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/02/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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