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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 Problem No Audible Alarm (1019)
Patient Problems Death (1802); Ventricular Fibrillation (2130)
Event Date 11/17/2020
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

The hospital's unit manager reported that a code blue event occurred the morning of (b)(6) 2020. The patient was in a paced rhythm then went into ventricular fibrillation, and with the change in rhythm, the red alarm for ventricular fibrillation did not sound. The patient was resuscitated then pronounced expired. The manager further stated that a hospital unit monitor technician reviewed the patient electrocardiograph strips (strips) and observed that a red alarm did not sound.

 
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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 Key10872118
MDR Text Key217295858
Report Number1218950-2020-07040
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 11/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
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 Received11/17/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/30/2014
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: 11/19/2020 Patient Sequence Number: 1
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