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

Model Number 865350

Device Problems No Audible Alarm (1019); Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 10/20/2022

Event Type  malfunction  

Event Description

The customer reported that their mx40 was displaying a speaker malfunction error message and that no audio could be heard from the device.The device was in clinical use when the issue was discovered however no patient harm was reported.

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Event Description

Statement of the reported problem: this report is based on information provided by philips bench repair personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the mx40 with a speaker malfunction.No patient or user harm were had.Visual inspection (if applicable): visual inspection found no speaker sound at start up.Functional testing/service repair/technical investigation: the following functional tests were performed: manual power test and network test.The device was taken apart at bench.Results of functional testing indicate a broken speaker.The speaker was replaced with a foxlink d speaker at bench.Confirmation: based on the information available and the testing conducted, the cause of the reported problem was a faulty speaker.The reported problem was confirmed further action decision: based on the information available and results of additional analysis, no further action is necessary at this time risk analysis: a review of the risk management file found that it is unclear whether the device was being used on or off the network.If the device is being used off network, in local monitor mode with no central station monitoring, and staff are not observing the device display, in the presence of life-threatening events when no sound is audible, serious injury and/or death can occur.Clinical harm review (if applicable): a clinical harm review was not required.Trending statement: the data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.Closure & product disposition: serviceable ¿ product back in service ¿ no further action required: the device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

This report was opened in error.The prior follow up was a completed report therefor this one is being closed with no additional information.

• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15718747
• MDR Text Key: 305009440
• Report Number: 1218950-2022-00959
• 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,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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 01/20/2023; 01/20/2023
• Supplement Dates FDA Received: 02/16/2023; 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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