MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING; TELEMETRY PATIENT MONITOR

Model Number 865350

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported the device gets too hot and may have burned a patient on the right shoulder.There is insufficient information provided to determine the severity of the burn.

Manufacturer Narrative

A philips product specialist engineer (pse) inspected the device and found visible corrosion on pin 4.Using a fluke hart scientific 1504 thermometer readout the pse performed a temperature test on the batteries which returned results of the batteries was 82 degrees fahrenheit versus ambient temp of 72 degrees fahrenheit.The reporting institution would not disclose further information related to the reported event; however, analysis of the returned device revealed no anomalies related to temperature.Based on this information, the extent of the burn remains unknown at this time, and it does not appear there was any device malfunction which would cause a burn.With the information available and the testing conducted, the cause of the reported problem was not confirmed.The lab tests shows device functioned as intended.The investigation concludes that no further action is required at this time.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: TELEMETRY PATIENT MONITOR
• 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: 18172502
• MDR Text Key: 328557591
• Report Number: 1218950-2023-00873
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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