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

Model Number 865351

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reports that the telemetry pack experienced a speaker malfunction and no noise.The device was not in use on a patient at the time of event, there was no patient involvement.

Event Description

The customer reports that the telemetry pack experienced a speaker malfunction and no noise.The device was not in use on a patient at the time of event, there was no patient involvement.

Manufacturer Narrative

The device was returned for evaluation at a philips authorized repair facility.Evaluation of the device determined the speaker produced audible sound.There was a speaker malfunction message present due to the use of a third party speaker.Evaluation of the device determined that the speaker did produce audible sound.

• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 13118592
• MDR Text Key: 283142815
• Report Number: 1218950-2021-11224
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 04/15/2022; 01/23/2023
• Supplement Dates FDA Received: 04/18/2022; 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2013
• 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