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

Model Number 865350

Device Problem Unintended Electrical Shock (4018)

Patient Problem Insufficient Information (4580)

Event Date 06/12/2023

Event Type  Injury  

Event Description

The customer reported the mx40 caused the battery to short circuit and burned a patient.

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.

Manufacturer Narrative

Philips received this complaint on the mx40 1.4 ghz smart hopping indicating that a patient got burned when aa battery overheated.Several good faith effort attempts were made to get additional information about the patient burn and the level of injury and patient outcome, but the customer did not respond.The device was returned to the philips authorized repair facility.Diagnostic and results of functional testing at the philips authorized repair facility indicate that the device had a broken battery compartment tab, corrosion and no spo2t sensor.There is no specific information regarding the overheating.The device was repaired per current process and returned to the customer.Based on the information available and the testing conducted, the cause of the reported problem was not confirmed.

• 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 rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17277933
• MDR Text Key: 318567414
• Report Number: 1218950-2023-00473
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• 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 Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other