MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 WLAN

Model Number 865352

Device Problem Defective Alarm (1014)

Patient Problem Ventricular Fibrillation (2130)

Event Date 07/04/2023

Event Type  Death  

Event Description

The customer reported that central unit did not alarm when a patient went into vf arrest.

Manufacturer Narrative

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

Manufacturer Narrative

New information received indicating that the event involved a patient death.Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Manufacturer Narrative

A technical investigation was performed by philips product support engineering.It was stated that looking at the clinical audit logs we can confirm the vent fib alarm was generated around the time mentioned.Additionally, after review of the provided pictures, corrosion at the centers of the battery contacts can result in increased resistance/impact to connection between the device and battery.It was also noted that some of the batteries being used are over 4 years old.The product ifu states that the battery will last for 4 yours or 500 complete charge/discharge cycles, as the battery ages, capacity can decrease by 25 ¿ 30%.If this is not acceptable, the battery should be replaced after two years.Efforts were made to have the faulty batteries sent for further evaluation but was not successful.A gfe (good faith effort) confirmed that the faulty standalone lithium batteries could not be shipped either by air or sea freight across by all carriers contacted.Based on the information available and the testing conducted, the cause of the reported problem was corrosion at the centers of the battery contacts due to old batteries above the recommended usage time.The reported problem was confirmed.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: INTELLIVUE MX40 WLAN
• Type of Device: INTELLIVUE MX40 WLAN
• 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: 17463339
• MDR Text Key: 320431406
• Report Number: 1218950-2023-00530
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865352
• Device Catalogue Number: 865352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 07/04/2023; 12/13/2023
• Supplement Dates FDA Received: 10/13/2023; 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2022
• 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; Required Intervention