MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

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

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the tele pack does not have sound.The device was not in use on a patient at the time of event.

Manufacturer Narrative

H10: the bench technician confirmed the customer's allegation was due to the mx40 telemetry device being tampered with and internal components were contaminated with silicone.Page 2 of the intellivue mx40 instructions for use states, ¿changes and modifications not expressly approved by philips medical systems can void your authority to operate this equipment under federal communications commission's rules¿¿ and ¿uses of the system for purposes other than those intended and expressly stated by the manufacturer, as well as incorrect use, incorrect operation, or modifications made to the system without explicit approval from philips, may relieve the manufacturer (or his agent) from all or some responsibilities for resultant noncompliance, damage or injury.¿ pages 156 and 158 of intellivue mx40 instructions for use state, ¿any changes or modifications to this equipment not expressly approved by philips healthcare may cause harmful radio frequency interference and void your authority to operate this equipment.¿ 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.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10974895
• MDR Text Key: 220918776
• Report Number: 1218950-2020-07609
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1