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

Model Number 453564262511

Device Problems Mechanical Problem (1384); Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

The customer reported that the device displays a lead set unplugged error and speaker malfunction.There was no reported adverse event to the patient or user.

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.

Manufacturer Narrative

Philips bench repair personnel confirmed that the device displays an error message that the device speaker malfunction.The device was operational after repairs were completed to the device speaker.

Event Description

The customer reported that the device displays a lead set unplugged error and speaker malfunction.There was no reported adverse event to the patient or user.

• Brand Name: TELE MX40, 1.4 GHZ, ECG AND SP02, EX
• Type of Device: TELE 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: jeanne ahearn ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16104324
• MDR Text Key: 308069515
• Report Number: 1218950-2023-00007
• 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: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 453564262511
• Device Catalogue Number: 453564262511
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• 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