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

Model Number 865350

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/01/2023

Event Type  Death  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported that the patient expired while being monitored on this mx40; the ecg stopped working.

Manufacturer Narrative

A philips product support engineer reviewed the log files provided.The available log data (rfda & device debug) does not show any loss of monitoring (loss of association with the pic ix) during the incident timeframe.The logs also show that the device was put into ¿standby¿ mode at 23:53 on (b)(6) 2023 and the device was taken out of ¿standby¿ mode at 00:40 on (b)(6) 2023.The only way the equipment can go into standby mode is through user interaction.When the mx40 is put into standby (either at the device or at the pic ix) the mx40 radio is turned off, as a result, no monitoring is being performed, and no data is being transmitted to the pic ix.The patient sector will show that the device is in ¿standby.¿ there are no other log entries until a battery replacement was performed at 08:25 on (b)(6) 2023, which was after the reported incident timeframe.Based on the limited information provided, the device was operating as specified during the event in question.Based on the information available and the testing conducted, the reported problem was not confirmed.The engineer provided their analysis findings.Based on the limited information provided, the device was operating as specified during the event in question.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 17617669
• MDR Text Key: 321889663
• Report Number: 1218950-2023-00600
• 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?: Yes
• 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: 08/01/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• 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
• Patient Outcome(s): Death