MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3150 INFO CNTR LOCAL DATABASE REL M.0

Model Number M3150

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the screen froze.The central station device was in use monitoring multiple patients when the issue occurred.There was no report of patient injury or harm.

Event Description

The customer reported that the screen froze.The ¿system¿ gives the appearance that it is working, however, the waves and parameter values are not updating.In some cases the clock (time) does not update and the mouse and keyboard do not respond.The central station device was in use monitoring multiple patients when the issue occurred.There was no report of patient injury or harm.

• Brand Name: M3150 INFO CNTR LOCAL DATABASE REL M.0
• Type of Device: M3150 INFO CNTR LOCAL DATABASE REL M.0
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6787575
• MDR Text Key: 82691183
• Report Number: 1218950-2017-05580
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2012
• 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