MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 2.4 GHZ SMART HOPPING

Model Number 865351

Device Problem Overheating of Device (1437)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Event Description

The customer reported that their telemetry box was overheating badly to the point where the battery compartment was burnt while in clinical operation.The customer also noted patient harm occurred though it is unknown what happened to the patient.

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.

Event Description

The customer reported that their telemetry box was overheating badly to the point where the battery compartment was burnt while in clinical operation.It was clarified that no user or patient harm occurred.

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.

Event Description

The customer reported that their telemetry box was overheating badly to the point where the battery compartment was burnt while in clinical operation.It was clarified that no patient harm occurred.

Manufacturer Narrative

Additional information was received indicating that no patient harm occurred.Further evaluation of the record clarified that no reportable event occurred, therefor this record is no longer reportable.

• Brand Name: MX40 2.4 GHZ SMART HOPPING
• Type of Device: MX40 2.4 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: 15798004
• MDR Text Key: 303648583
• Report Number: 1218950-2022-00981
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,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: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 12/06/2022; 12/06/2023; 12/06/2023
• Supplement Dates FDA Received: 12/21/2022; 01/05/2023; 02/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2023
• 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): Other