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

Model Number 865350

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported no audio from the mx40.It is unclear whether the device was being used on or off the network.There was no patient involvement.There was no report of patient injury or harm.

Manufacturer Narrative

(b)(4).

• 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 rd.; andover MA 01810
• Manufacturer Contact: nancy ataide ; 3000 minuteman rd.; andover, MA 01810 ; 9786597429
• MDR Report Key: 4381653
• MDR Text Key: 15321777
• Report Number: 1218950-2014-07764
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/03/2014

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: 865350
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1