MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC TELE MX40, 2.4 GHZ, ECG &SP02, EXCHANGE

Model Number 453564262551

Device Problems Device Alarm System (1012); Audible Prompt/Feedback Problem (4020)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2022

Event Type  Death  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the vital signs of telemetry monitored (mx40) patients were not displayed in the pic ix central monitoring system and their alarms were not transferred to the pic ix central monitoring system.The failure caused a disturbance in the ward, as a result of which one patient died.

Event Description

The customer reported that the vital signs of telemetry monitored (mx40) patients were not displayed in the pic ix central monitoring system and their alarms were not transferred to the pic ix central monitoring system.The failure caused a disturbance in the ward, as a result of which one patient died.

Manufacturer Narrative

A philips service operations manager (som) contacted the customer biomedical engineer (biomed).Per the som, it was not known exactly whether the mx40 device had alerted about the battery running out.If it did the end users had not heard or noticed it.Mx40 were not connected to pic ix central monitoring.The mx40 battery end log data was not available because the its system was down, thus the log data was not updated to the pic ix system.Running out of the mx40 battery is the likely reason that the device had turned off, because the mx40 device had returned to normal operation as soon as its battery was replaced.The som indicated that the root cause for the its system down turned out to be a network hardware failure; the trunk fiber cable between the data switches failed.The fault was fixed by the hospital's biomed/ict staff the next day.The device remains at the customer site.

Event Description

The customer reported that the vital signs of telemetry monitored (mx40) patients were not displayed in the pic ix central monitoring system and their alarms were not transferred to the pic ix central monitoring system.The failure caused a disturbance in the ward, as a result of which one patient died.

• Brand Name: TELE MX40, 2.4 GHZ, ECG &SP02, EXCHANGE
• Type of Device: TELE MX40, 2.4 GHZ, ECG &SP02, EXCHANGE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 15632063
• MDR Text Key: 302005950
• Report Number: 1218950-2022-00923
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2022

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: 453564262551
• Device Catalogue Number: 453564262551
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 09/20/2022; 09/20/2022
• Supplement Dates FDA Received: 12/02/2022; 12/12/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 87 YR
• Patient Sex: Male
• Patient Weight: 77 KG