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

Model Number 865350

Device Problem No Audible Alarm (1019)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

A philips remote service engineer (rse) spoke with the customer.The customer was trying to troubleshoot the error in the pic ix.The rse explained to the customer that the error message was coming from the mx40 device because the mx40 had a speaker malfunction.The rse advised the customer to switch out the mx40 and the message went away.The rse offered the customer bench repair, however, the customer is taking responsibility for servicing the device.A good faith effort (gfe) was made to obtain additional information on this issue and resolution, but no information regarding the mx40 was provided.The reported problem was not able to be confirmed.If additional information is received the complaint file will be reopened.H3 other text : customer is taking responsibility for servicing the device.No further information provided.

Event Description

Philips received a complaint on the philips patient information center ix (pic ix) indicating there was a speaker malfunction message in the patient window.It is unknown if the speaker was able to produce sound.The device was in use at the time of the event.No adverse event or patient harm was reported.

• 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: 18953971
• MDR Text Key: 338380132
• Report Number: 1218950-2024-00212
• 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: 03/21/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2015
• 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