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

Model Number 866389

Device Problem No Audible Alarm (1019)

Patient Problem Cyanosis (1798)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Patient information has been requested, not available at time of report.Date of incident requested not available at time of report.

Event Description

The nurse stated that they saw a red alarm trigger, but did not hear an audible alarm.The patient turned to a shade of blue per the hospital biomed.

Manufacturer Narrative

There was no product malfunction; this was a user issue, as the user had silenced the alarms at the pic ix.Alarms had been generated from 11:49 to 12:39, including several destat alarms; these alarms were silenced.The biomed checked the bedside and pic ix, and found both alarming audible and visual; no issue found.The device remains at the customer site.No further investigation 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: 8312310
• MDR Text Key: 135224094
• Report Number: 1218950-2019-00973
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645
• 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: 01/11/2019

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: 01/11/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2017
• 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 Age: 60 YR