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

Model Number 865350

Device Problems Protective Measures Problem (3015); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

The customer reported that the patient coded on box and they want all the information retrieved from the box.The device was in use at time of event, there is insufficient information regarding patient impact at time of report.

Manufacturer Narrative

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

Manufacturer Narrative

The remote service engineer (rse) states that there are no allegation of failure for the mx40.The rse confirmed via good faith effort (gfe) that the customer wanted the information from the box retrieved.Based on information in the case, the customer requested information from the tele box to be provided, no allegation or failure of the device was alleged.The investigation concludes that no further action is required at this time.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,
• 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: 18408866
• MDR Text Key: 331492782
• Report Number: 1218950-2023-00975
• 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: 12/28/2023
• 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: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2017
• 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