MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE DATABASE SERVER; CENTRAL STATION MONITOR

Model Number M3154

Device Problem Device Stops Intermittently (1599)

Patient Problem Cardiac Arrest (1762)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer stated that their piic classic system went down for 7 minutes and then came back up.During this time, a patient coded that was being monitored on this system.

Manufacturer Narrative

Philips cannot rule out a malfunction of the device, as attempts to obtain additional information have been unsuccessful.No parts have been ordered and no repair was found to be initiated.We will consider that the device remains in use at the customer site, as no subsequent calls have been logged from this customer for this type of device/issue.No further investigation or action is warranted at this time.Should additional information become available, this report will be reopened for an investigation.

• Brand Name: INTELLIVUE DATABASE SERVER
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7608097
• MDR Text Key: 111309809
• Report Number: 1218950-2018-04949
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3154
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2009
• 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
• Patient Outcome(s): Life Threatening