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

Model Number 865350

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

At the repair bench it was found that there was no audio from the speaker.There was no pt involvement.There was no pt involvement.There were no reports of pt 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: 4360015
• MDR Text Key: 19719851
• Report Number: 1218950-2014-07675
• 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: 10/15/2014

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: Other
• Device Model Number: 865350
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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