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); Fall (1848)

Event Date 04/25/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer clinical engineer (biomed) reported that a nursing discovered that a patient had fallen off their bed (l5605-01).The nurse notified clinical engineering; no alarm conditions were indicated at the philips information center ix (pic ix) from the telemetry device connected to the patient (mx40).When asked whether mx40 leads ever disconnected from the patient, the answer was no.However, nursing stated they should have received an asystole alert for this bed.The patient was reported to have died four days later.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site.The fse tested the mx40, and found it was working with no issue, and verified the connection to the nearest network access point (ap).The fse was not able to test the pic ix at the time, however, the customer biomed confirmed with the philips complaint investigator (ci), that both the mx40 and piic ix involved were tested and verified to be working properly.The fse obtained alarm logs from the pic ix for this incident, which was verified to have occurred between 11:22pm-11:23pm on (b)(6) 2020.The alarm log was reviewed by the ci.An asystole alarm was seen to have occurred during this time at 23:22:57.Additional alarms occurred during this time, until 23:31:18 and the alarms were silenced; the asystole then ended at 23:31:31.The fse noted that the philips products were rebooted the next day.The customer also asked for activity from (b)(6) 2020 at 21:58 to (b)(6) 2020 at 22:49.Follow-up with the customer by a philips clinical specialist (cs) was performed.The customer indicated that they found no issues with the pic ix or the patient worn device (mx40); both devices remained in use.There was no product malfunction; this is considered a user issue.The pic ix alarm logs were reviewed, and the device alarmed for asystole, during the time it was alleged to not have alarmed; the alarm was eventually silenced.Additional alarms occurred after this event with reminders being sent, until the patient showed being transferred to another bed.No further investigation or action is warranted at this time.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLIVUE INFORMATION CENTER IX
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10060984
• MDR Text Key: 191106192
• Report Number: 1218950-2020-02845
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645
• Combination Product (y/n): N
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR