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

Model Number 865350

Device Problem Alarm Not Visible (1022)

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

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

A philips remote service engineer (rse) verified that there was an inoperative (inop) alarm stating some ecg alarms were off.The rse instructed he customer biomedical engineer (biomed) to enter the ecg setup menu by touching heart rate (hr>arrhythmia>turn arrhythmia on), and recommended attempting to activate a red level alarm on a simulator while assigned to sector on the philips information center ix (pic ix).The biomed put a hold on the recommended steps suggested by the rse for the following day and would call back to confirm.They stated the mx40 was back in service and not having any issues now.Further details were requested, but not able to be provided, as the repair was from another biomed on site and not the case owner.Based on the information available and the testing conducted, the cause of the reported problem was unknown.The reported problem was not confirmed.Philips was unable to confirm the final disposition of the device because the customer took responsibility to correct/repair the device.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

The customer reported that mx40 1.4 ghz smart hopping device alarms were not displaying.The device was not in clinical use at the time the issue was discovered; this was noticed while using a simulator.No adverse event or 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: 17884900
• MDR Text Key: 325069670
• Report Number: 1218950-2023-00733
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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: 09/18/2023
• Initial Date FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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