MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIIC IX HARDWARE; CENTRAL STATION MONITOR

Model Number 866424

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 02/27/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported the spo2 parameter disappears in a sector when the sector is minimized.A patient expired on approximately (b)(6) 2020.The customer is asking for help in determining if the patient was tampering with the telemetry device or if the patient had removed the device leading up to a code event.They need to understand and if there was a delay in response, absent inop alarm, etc.That contributed to death.

Manufacturer Narrative

H3 and h6: a philips field service engineer (fse) went to the customer site.The customer had questions for a specific part of the philips information center ix (pic ix) alarm audit log.The fse obtained the alarm audit logs from the pic ix.The log was provided to a philips complaint investigator (ci), and reviewed.The log data showed that the philips patient worn monitor (mx40) was taken offline and arrhythmia alarms were off at 4:06am.The device was brought back online, along with the arrhythmia alarms, at 4:07am.A leadset unplugged alarm occurred at 4:07, and then a ecg leads off alarm occurred at 4:10:09; both of these alarms ended during the minute of 4:10am.Finally, at 4:11am, the alarms were silenced.Follow-up information was received, and per the nurse manager, the patient was not on the monitor; the physician team had removed the monitor and was performing a procedure in the room when the patient coded and was defibrillated.A philips clinical specialist (cs) was provided the alarm audit log who indicated that the equipment was seen going offline a lot and coming back rather quickly (which could suggest an ap problem).There were also a lot of ecg leads off and leadset unplugged alarms, which the cs believed may have been due to a combatant patient.There was no product malfunction.The physician's team had removed the ecg leads and taken the patient worn device offline; multiple other ecg leads off and leadset unplugged alarms were also believed to have been due to a combatant patient.The device remains at the customer site.No subsequent calls have been logged for this device/issue.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: PIIC IX HARDWARE
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9897831
• MDR Text Key: 185520893
• Report Number: 1218950-2020-01994
• Device Sequence Number: 1
• Product Code: MHX
• 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: 03/09/2020

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: 866424
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death