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

Model Number 866389

Device Problem Device Alarm System (1012)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 11/16/2020

Event Type  Death  

Manufacturer Narrative

A philips clinical specialist (cs) went to the customer site on (b)(6) 2020, and the customer biomedical engineer (biomed) stated that the ecg leads off alarm had been red prior to upgrades performed in (b)(6) of 2020.Due to the unit being full with covid-19 patients, the monitor was not accessible to see what the current alarm was sent.The alarm review was checked and a yellow alarm was triggered.The hospital only had red alarms sent to the nurses phones.The pic ix configuration was changed to page out the yellow ecg leads off alarm.Both biomed and nursing were in agreement with this process until the replacement monitors were to be ordered in the first quarter of 2021.On (b)(6) 2020, the cs received a phone call from the biomed requesting that the cs speak with the risk manager regarding an rca that they were doing on the patient , as the patient had subsequently expired.The rca team was requesting information regarding how alarms are set and how they paged to the nurses.The director of critical care stated that they had some rooms closed so that philips could go in and look at the monitors.The cs did pull up the configuration both pre and post upgrade; both configurations did have the alarm as "red".The cs questioned if the wrong configuration was pushed into the monitor.On (b)(6) 2020, the cs went to the hospital imc unit to look at the monitors in the empty rooms.The correct configuration was in the monitors.It was discovered that the default profile was profile adult; the correct profile should have been imc adult.The profile that defaulted did not have all ecg leads off as a red alarm; therefore, did not send the alarm to the phone.It was set as a yellow alarm and it did respond as anticipated-alarmed yellow at the philips information center ix (pic ix), but did not go to the phone.When the cs created the configuration, the cs failed to change the default to imc adult.The cs was not onsite when they were upgraded; therefore, did not catch the mistake.

Event Description

The customer provided feedback that on (b)(6) 2020, an "ecg leads off" alarm was not paged to the nurse and a patient was found in cardiac arrest.The patient was resuscitated, however, a philips clinical specialist (cs) was informed on (b)(6) 2020 that the patient later expired.

• 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: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 11266611
• MDR Text Key: 229871031
• Report Number: 1218950-2021-00708
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838086715
• UDI-Public: (01)00884838086715
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/28/2020

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: 11/16/2020
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2020
• 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): Death