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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 Problems Overheating of Device (1437); Excessive Heating (4030)
Patient Problems Burning Sensation (2146); 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.
 
Manufacturer Narrative
The mx40 patient worn monitor device (¿device¿) was returned to philips on march 23, 2021.The lead set, aa batteries, and battery adapter tray involved in this incident were not returned to philips for evaluation, nor were pictures provided.The fse requested additional information on the incident reported above and was informed by your hospital that the nurse reported the lead set was warm, but no heat was felt on the mx40.The fse was also informed the lead set was discarded and the lot number is unknown.The burn was treated with cream and band aids.It was reported that the battery adapter tray involved in the reported incident was corroded and discarded.A philips product support engineer (pse) examined the device.The pse found that there was no corrosion or chemical residue at the connector pins or battery contacts.The gore-tex vent cover inside the battery compartment is discolored (yellowed).This is typically chemical related and is consistent with use of bleach.The pse then performed testing on the device and the device was powered on using 3 aa batteries and connected to a product support engineering lab patient simulator (with pse lab patient cable).The device was operated for one hour, with no overheating of the batteries or device.During operation, the device alarmed as appropriate for simulated heart rate conditions.The device spontaneously rebooted three times while it was in operation.One reboot occurred when the device was picked up and tapped lightly on the side.This may be due to the wear to the battery adapter tray that was returned with the device.Measurements were performed at the device connector using a multi-meter while the device was powered on.No shorts were measured, and no voltage was measured that would cause burns or shocks to a patient or user.The aa batteries and battery adapter tray were removed from the device and a pse lab philips rechargeable li-ion battery was inserted into the device.The device was operated for one hour, with no overheating of the device or battery.During operation of the device with both aa batteries and a philips rechargeable li-ion battery the patient cable/leads did not get hot.The device¿s speaker produced clear, audible tones during operation (including for generated alarms).The patient cable that was in use at the time of the incident was also requested for evaluation; however, it was not returned with the device.The condition of the cable is not known.Note that the patient cable cannot generate energy that would shock or burn a patient or user.Based on our investigation, there is no evidence that the mx40 patient worn monitor device overheated or delivered energy through the connector that would have caused a burn to a patient or user.The device was returned to the customer.
 
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.The device was in clinical use and the patient's chest was burned.
 
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Brand Name
MX40 1.4 GHZ SMART HOPPING
Type of Device
MX40 1.4 GHZ SMART HOPPING
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key11059530
MDR Text Key223730620
Report Number1218950-2020-08029
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838082236
UDI-Public(01)00884838082236
Combination Product (y/n)N
PMA/PMN Number
K113125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Was the Report Sent to FDA? No
Date Manufacturer Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age57 YR
Patient Weight120
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