MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 2.4GHZ; PATIENT MONITOR

Model Number 865351

Device Problem Device Alarm System (1012)

Patient Problem Bradycardia (1751)

Event Date 07/11/2023

Event Type  Death  

Event Description

Philips received a complaint indicating the patient information center ix (piicix) did not alarm on a bradycardia alarm (extreme brady limit was set on 35).The device was in clinical use during the event.The patient's heartbeat slowed down so much that the patient expired.The pic ix device involved in this event is reported in mfr 1218950-2023-00566.

Manufacturer Narrative

The log was reviewed by the clinical application specialist (cas).The log data shows that a red asystole alarm was generated at 10h37 and the alarm was not acknowledged by a caregiver.Based on this information and an audit log review by clinical application, the device alarmed per configuration.It was noted a previous asystole alarm had been generated but never acknowledged by the user.As the asystole condition is higher priority in the alarm chain, there was no alarm for extreme brady.The asystole alarm was generated for 1 hour and 37 minutes.Based on this information, the device performed per configuration and did not cause or contribute to the reported event.The reported event may potentially be related to clinical workflow or alarm management; however, the cause remains unknown.

• Brand Name: INTELLIVUE MX40 2.4GHZ
• Type of Device: PATIENT MONITOR
• 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: 17546837
• MDR Text Key: 321130283
• Report Number: 1218950-2023-00567
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 57 KG