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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 Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 02/10/2021
Event Type  Injury  
Event Description

The hospital biomed requested assistance in obtaining logs. It was reported a patient was harmed and the customer needs log information to see if it was a device error or not. Additional information about incident and patient was requested. The device was in use on a patient at the time of event and adverse event reported.

 
Manufacturer Narrative

The device was not expected to be returned for evaluation. Good faith efforts were made to discover the event details, however no additional information was provided.

 
Event Description

The hospital biomed requested assistance in obtaining logs. It was reported a patient was harmed and the customer needs log information to see if it was a device error or not. Additional information about incident and patient was requested. The device was in use on a patient at the time of event and adverse event 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
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
derek sammarco
222 jacobs street
cambridge, MA 02141
MDR Report Key11425105
MDR Text Key238312188
Report Number1218950-2021-10085
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
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2021
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 Date02/10/2021
Event Location No Information
Date Manufacturer Received02/10/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/06/2011
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: 03/05/2021 Patient Sequence Number: 1
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