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

Model Number M3150

Device Problem Defective Alarm (1014)

Patient Problems Death (1802); Respiratory Distress (2045)

Event Date 04/20/2020

Event Type  Death  

Manufacturer Narrative

A philips response center engineer (rce) spoke to the customer biomedical engineer (biomed).This issue occurred on (b)(6) 2020 on a patient in bed space "mon12".The biomed stated that the philips intellivue information center (piic) system alarmed several times at the ** yellow level, hours before the patient's passing.Those alarms were "acknowledged"; the last was time at 21:15.After 21:15, the patient had consistently been around 93% in saturation, which does not cause any alarms, as the alarm limit for low saturation was 90%.According to the biomed, the patient was likely to have cardiac arrest at 21:57.This cannot be seen at the control panel since arrhythmia monitoring was not enabled.The cardiac arrest, in turn, causes the patient to have no heart rate.A philips clinical specialist (cs) reviewed the alarm logs with the rce, and found the following.At 19:27, the arrhythmia analysis has been switched off.If the staff switched off ecg / arrhythmia, this also includes heart rate alarms.For this reason, the monitor will not alert for extreme bradycardia (asystole).Furthermore, the missing pulse will result in the signal quality becoming inferior.The spo2 measurement will then very properly send one of the following technical alarms (blue alarms): "spo2 noisy signal", "spo2 no pulse".This alarm indicates that there is a technical problem that involves reduced or non-existent ability to reliably monitor the patient.The rce and cs determined that the monitor has done what it should on the basis of the given conditions.If the staff wants to monitor cardiac activity reliably, the ecg must be connected to the patient.Based on the alarm log, the rce and cs confirmed that at 19:27, the arrhythmia monitoring had been completely switched off; this was done from the bedside.There was no product malfunction; this is considered a user issue, as the alarms had been turned off for arrhythmia monitoring prior to the patient's death.This information was provided to the customer.The device remains at the customer site.No further investigation or action is warranted at this time.

Event Description

The customer reported that a patient arrived as a respiratory distress alarm and was treated as suspected of covid-19.The alarm nurse who resolves for the night receives a report from the evening's alarm nurse that the patient awaits hospitalization and is stable.The journal states that the patient is connected to telemetry, but only blood pressure and saturation are connected and measured.When the responsible doctor goes in for a status update, the patient is deceased.It has not alarmed on the monitoring screen.The last measurable blood pressure was at 21:40 and at 21:50 a saturation of 93% was measured.The patient died.

• Brand Name: INTELLIVUE INFORMATION CENTER
• 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: 10001003
• MDR Text Key: 189010865
• Report Number: 1218950-2020-02489
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/22/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: M3150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2010
• 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