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

Model Number 865350

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2021

Event Type  malfunction  

Event Description

The speaker malfunction message was displayed on the mx40 itself; however, local audio was not confirmed.No patient involvement.

Manufacturer Narrative

The remote service engineer advised the biomed to send the device in for repair.The device was not sent for repair nor was product identifying information provided.The device remains at the customer site.

Event Description

The customer reports that the mx40 has a "speaker malfunction" inop/ error code but was unable to confirm local audio.The device was not in use on a patient at the time of the event.

• 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
• MDR Report Key: 11396386
• MDR Text Key: 234210173
• Report Number: 1218950-2021-10053
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/14/2021
• Date Manufacturer Received: 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1