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

Model Number 865350

Device Problem Device Alarm System (1012)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device was sent to philips authorized repair facility (rft) for bench for evaluation.Diagnostic/functional testing was performed at the philips authorized repair facility.Results of functional testing indicate that the speaker produced audible sound.Although the speaker was confirmed to produce sound during testing.Device was repaired and operational and returned to the customer.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.

Event Description

Philips received a complaint on the mx40 1.4 ghz smart hopping indicating mx40 transmitter displays message "speaker malfunction" it is unknown if sound was audible at central station computer when the speaker malfunction" was observed.It is unknown if the device was in use at time of event, and there was no adverse event reported.

• 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: 18466341
• MDR Text Key: 332739083
• Report Number: 1218950-2024-00018
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2019
• 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