MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS TELE MX40, 1.4 GHZ, ECG AND SP02, EX

Model Number 865350

Device Problem No Audible Alarm (1019)

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

Event Date 11/10/2023

Event Type  malfunction  

Event Description

Philips received a complaint on the mx40 1.4 ghz smart hopping indicating that the device was not alarming ventricular tachycardia.The device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

Philips remote clinical support confirmed device configuration.The customer was advised that based on the current device configuration, the patients hr did not go over 122 so this did not violate the hr portion of the vtach alarm.Both would need to be violated at the same time to produce the vtach alarm.Based on the information available the reported problem was not confirmed.If additional information is received the complaint file will be reopened.

• 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 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: 18294467
• MDR Text Key: 330072505
• Report Number: 1218950-2023-00914
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2020
• 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