MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2022

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that on (b)(6) 2022 a patient was found dead on toilet.Nurses said that the patient was connected to mx40 telemetry failed to alarm.The device was in use at time of event and a patient death was reported.

Event Description

The customer reported that on (b)(6) 2022, a patient was found dead on toilet.Nurses said that the patient was connected to mx40 telemetry failed to alarm.The device was in use at time of event and a patient death was reported.Upon review with the product support engineer, it was confirmed that there was a power interruption on the device during the time of the reported incident.The device failed to reboot after the power disruption.Based on the review performed by the product support engineer, it is not possible to rule out the cause for device's failure to provide physiological alarms, although it was confirmed that there was power interruption at the time.Based on the results from the investigation, it is concluded that the device failed to perform as intended, although the potential cause cannot be ruled out.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15224220
• MDR Text Key: 297875591
• Report Number: 1218950-2022-00716
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• 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: Other
• 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?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2021
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 53 KG