MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC TELE MX40, 2.4 GHZ, ECG &SP02, EXCHANGE

Model Number 453564262551

Device Problems No Audible Alarm (1019); No Device Output (1435)

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

Event Date 09/07/2022

Event Type  malfunction  

Event Description

The customer reported that the device displayed "speaker malfunction" and had no sound.The device was not in use on a patient at the time of event, there was no patient involvement.

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the device displayed "speaker malfunction" and had no sound.The device was not in use on a patient at the time of event, there was no patient involvement.

Manufacturer Narrative

The customer reported that the device displayed "speaker malfunction" and had no sound.A philips remote service engineer (rse) confirmed the event was caused by a hardware malfunction.He customer was advised to order an exchange transmitter.

• Brand Name: TELE MX40, 2.4 GHZ, ECG &SP02, EXCHANGE
• Type of Device: TELE MX40, 2.4 GHZ, ECG &SP02, EXCHANGE
• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15406529
• MDR Text Key: 300051177
• Report Number: 1218950-2022-00879
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 453564262551
• Device Catalogue Number: 453564262551
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Date Device Manufactured: 06/21/2017
• 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