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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING

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PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING Back to Search Results
Model Number 865350
Device Problem Alarm Not Visible (1022)
Patient Problem Insufficient Information (4580)
Event Date 04/16/2021
Event Type  Death  
Manufacturer Narrative

(b)(4). A death was reported, but not other information was provided at time of report.

 
Event Description

The customer reported the telemetry device went from operational to no signal state with no alert. The biomed found the device had a broken case which prevented the battery from being secure. It was reported the potential safety issue of this case is related to a death. The device was in use on a patient at the time of event. A patient death was reported.

 
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Brand NameMX40 1.4 GHZ SMART HOPPING
Type of DeviceMX40 1.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
222 jacobs street
cambridge MA 02141
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
222 jacobs street
cambridge MA 02141
Manufacturer Contact
derek sammarco
222 jacobs street
cambridge, MA 02141
MDR Report Key11811485
MDR Text Key250175294
Report Number1218950-2021-10525
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 FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2021
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/16/2021
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated By Manufacturer? No
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: 05/12/2021 Patient Sequence Number: 1
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