• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING Back to Search Results
Model Number 865350
Device Problem Overheating of Device (1437)
Patient Problems Burn, Thermal (2530); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  Malfunction  
Manufacturer Narrative

The customer's problem description is further stated as the box burned a patient on the chest. The nurse states on the report the battery tray was corroded.

 
Event Description

The customer reported the on the (b)(6) 2020, while using the mx40 telemetry device the patient complained of a burn on their left chest. The nurse reported the leadset was warm but no heat was felt on the mx40. The leadsets were discarded. The burn was treated with cream and band aids.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key11059530
MDR Text Key223730620
Report Number1218950-2020-08029
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
Report Date 11/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2020
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 Received11/24/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/17/2018
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: 12/22/2020 Patient Sequence Number: 1
-
-