MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE INFORMATION CENTER IX; CENTRAL STATION MONITOR

Model Number 866389

Device Problem Device Alarm System (1012)

Patient Problem Ventricular Tachycardia (2132)

Event Date 04/13/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that an alarm did not go off on a piic ix when a patient experienced vtach rhythm on (b)(6) 2019.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site.It was determined that there was no product malfunction as the user had silenced alarms, just prior to the expected vtach alarm.It was also noted that the default profile appeared to have been changed.This information was provided to the customer.The device remains in use at the customer site.No subsequent calls have been logged for this device/issue.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE INFORMATION CENTER IX
• 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: 8527380
• MDR Text Key: 142359202
• Report Number: 1218950-2019-02919
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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