MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

The customer reported a malfunction of the speaker on the mx40 monitor.It is unknown if sound was still coming from the device.It is unknown if the device was in use monitoring a patient at the time of the reported issue.No adverse patient or user event was reported.

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 received a complaint on the mx40 1.4 ghz smart hopping indicating a malfunction of the speaker on the mx40 monitor.It is unknown if sound was still coming from the device.The device was received at the philips authorized repair facility (rft) for bench evaluation on 8/3/2023 but was labelled as a discrepant unit because the serial number (sn) on the device received did not match the incoming paperwork.The sn on the device received was (b)(6).Sn (b)(6) was already returned back to the customer on 12/6/2023.A device for sn (b)(6) has not been received by the philips authorized repair facility for evaluation, therefore, the complaint allegation cannot be confirmed.Based on the information available and the testing conducted, the cause of the reported problem was not confirmed.The customer was provided the information to return the device to bench repair, however, as of (b)(6) 24, there is no evidence that the device has been returned.Since the device has not been received for evaluation, the cause of the reported allegation is undetermined.If additional information is later obtained, the complaint will be reassessed and updated accordingly.H3 other text : device was not sent in to bench repair.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• 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: 18245215
• MDR Text Key: 329434114
• Report Number: 1218950-2023-00901
• 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

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2017
• 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