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

Model Number 865350

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 04/18/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer requested that a field service engineer (fse) be dispatched to investigate why the mx40 device was not monitoring a patient.Patient incident occurred.Additional information regarding the incident was requested, but no response has been received.Upon inspecting clinical audit logs noticed user assigned incorrect equipment label to sector being monitored.Issue cleared up when user assigned correct equipment label.The device was in use on a patient at the time of event.There was an adverse event reported.

Manufacturer Narrative

A philips field service engineer (fse) was dispatched for onsite support.The fse reviewed the clinical audit logs and noticed that the user assigned an incorrect equipment label to the sector being monitored.The user correctly assigned the equipment label and the issue was resolved.Attempts were made via the fse to obtain additional information regarding the reported incident patient, but unfortunately, our attempts went unanswered.Based on our investigation, philips has determined that the mx40 device was working as designed.

Event Description

The customer requested that a field service engineer (fse) be dispatched to investigate why the mx40 device was not monitoring a patient.Patient incident occurred.Additional information regarding the incident was requested, but no response has been received.Upon inspecting clinical audit logs noticed user assigned incorrect equipment label to sector being monitored.Issue cleared up when user assigned correct equipment label.The device was in use on a patient at the time of event.There was an adverse event reported.

• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14381061
• MDR Text Key: 291592106
• Report Number: 1218950-2022-00397
• 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: 04/20/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 08/01/2022
• Supplement Dates FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2016
• 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): Required Intervention