MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING

Model Number 865351

Device Problems No Audible Prompt/Feedback (2282); Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

The customer was provided with a quote for a replacement device.The device remains at the customer site and will not be returned.The customer was sent a replacement device but it will be returned by the field service engineer.It is at the customer's discretion to proceed with a purchase or service order.No further actions were taken and there were no subsequent calls related to this issue.

Event Description

The customer reported that the speaker is defective.No confirmation was provided on whether sound was audible.The device was not in use on a patient.

• Brand Name: MX40 2.4 GHZ SMART HOPPING
• Type of Device: MX40 2.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 10815884
• MDR Text Key: 217089301
• Report Number: 1218950-2020-06777
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: (01)00884838082243
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• 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