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

Model Number 866389

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that yellow alarm occurred for a patient in bed 9-2 b2 that should have been a red alarm.The patient ended up with a pacemaker implanted during the night.

Manufacturer Narrative

Data from this event, including alarm audit logs, and patient strips, for this event were provided to a philips senior clinical specialist (scs) for review.The scs found that the patient had properly labeled the beats, but the heart rate (hr) was too slow to call the alarm.Vtach requires two thresholds to announce: the number of pvcs in a row and the hr.Also, there can be up to 16 ¿templates¿ of each individual lead.Sometimes ventricular beats were previously labeled as normal, so when they occur again, the system thinks it is normal.Per the st/ar algorithm application note: manual relearn: a manual relearn should be initiated if beat detection is not occurring, or if beat classification is incorrect resulting in a false alarm.Remember, if the same signal condition exist which caused the algorithm to performed poorly, relearning will not correct the problem.The problem can only be corrected by selecting a different lead a philips field service engineer (fse) onsite informed the customer biomedical engineer (biomed) that the staff should: · do a relearn at the central station, · check that the patients ecg electrode are placed correct according to the telemetry transmitter config (easi; standard), · check that primary and secondary leads are optimally placed, · print out relevant alarms on paper.There was no product malfunction; the cause was determined to be related to the patient's heart rate being to slow to call the alarm, because a vtach alarm requires two thresholds to announce: the number of pvcs in a row and the hr.The customer was informed of the investigation results.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: 9695259
• MDR Text Key: 178629215
• Report Number: 1218950-2020-01022
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838086715
• UDI-Public: (01)00884838086715
• Combination Product (y/n): N
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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: 02/07/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 02/07/2020
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 96 YR