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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC TELE MX40, 1.4 GHZ, ECG AND SP02, EX

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PHILIPS NORTH AMERICA LLC TELE MX40, 1.4 GHZ, ECG AND SP02, EX Back to Search Results
Model Number 865350
Device Problem Low Audible Alarm (1016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  Malfunction  
Event Description

The customer reported that the telemetry device has a speaker malfunction. The device was not in use on a patient at the time of event, there was no adverse event reported.

 
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Brand NameTELE MX40, 1.4 GHZ, ECG AND SP02, EX
Type of DeviceTELE MX40, 1.4 GHZ, ECG AND SP02, EX
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 Key11865353
MDR Text Key252015224
Report Number1218950-2021-10577
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
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
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?
Distributor Facility Aware Date04/30/2021
Event Location No Information
Date Manufacturer Received04/30/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/10/2019
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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