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

Model Number 865351

Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The customer reported that the mx40 displays a speaker malfunction inop.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

H10: the customer communicated with a philips remote service engineer (rse).The rse confirmed that sound was audible and the system displayed a speaker inop.The customer requested an exchange device and license transfer.At the time of this investigation, the device has yet to be returned.In the event that the device is returned, the record shall be reopened for further evaluation.The root cause of the reported failure cannot be determined as the device was not returned for evaluation.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.H3 other text : the device has not been returned for evaluation.The customer was provided with a replacement device.

• 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
• MDR Report Key: 10463462
• MDR Text Key: 205890722
• Report Number: 1218950-2020-04981
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1