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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 No Audible Alarm (1019); Alarm Not Visible (1022); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Death (1802)
Event Date 04/10/2020
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

The customer's director biomedical and clinical engineering (htm) reports that on (b)(6) 2020 the patient was found expired by nurse at 11:30am mdt and reports no alarming for spo2. The customer reports that the device was showing a spo2 of 90 but the actual reading was supposed to be 71. The patient room was confirmed and the clinical audit trial shows alarming between 10-54am -12:28pm with equipment removal of the device at 13:18 mst. Investigation is being conducted to determine if the device caused or contributed to the event.

 
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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
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key9958599
MDR Text Key187592029
Report Number1218950-2020-02286
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 04/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number865350
Device Catalogue 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 Received04/13/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/18/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/14/2020 Patient Sequence Number: 1
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