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

Model Number 866389

Device Problem Loss of Power (1475)

Patient Problems Cardiopulmonary Arrest (1765); Dyspnea (1816)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a patient had a respiratory decompensation, was found disconnected from a bilevel positive airway pressure (bipap) device, coded and transferred to icu.During the customer investigation, one of the opportunities identified was related to all spo2 alarms being turned off.Staff went to turned them all spo2 alarms on and the next day, they were off again.The patient coded.

Manufacturer Narrative

The report of the spo2 alarms being turned off was not verified during the review of the alarm log by a philips clinical product specialist (cps).The measurement itself was turned on at the central at 20:11.On (b)(6) 2019 at 23:04, the patient was transferred to phn01.At this time, the unit default settings were applied to bed 70101.This included the spo2t alarm on, and the high limit of 100, a low limit of 92 and a desat limit of 92.These defaults are applied to the bed at the time of either discharge or transfer to another bed.The spo2t measurement was then seen to be turned off at 11:20 on (b)(6) 2019.The cps reviewed the available audit logs, and found that the spo2t alarms were on as of 23:04.However, there were no signs of spo2 alarms sounding.The default mode for spo2t monitoring for the telemetry unit used with this patient is "manual", which was applied at the time of the transfer out at 23:04 the evening before.There is no indication that the this mode was changed to continuous.There were many other types of alarms that preceded the incident, including red alarms for extreme tachycardia, and yellow alarms for high resp rate.There was no product malfunction; this was a configuration issue.The spo2t alarms did not occur, because the spo2t measurements were not taken manually.It is recommended by the philips clinical product specialist that the spo2t mode be set to a default of ¿continuous¿ for all patients, and then turned to "manual" if needed for those patients that do not require continuous spo2 monitoring.The device remains in use at the customer site.No subsequent calls have been logged for this device/issue.No further investigation or action is warranted at this time.

• 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: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8939620
• MDR Text Key: 155846144
• Report Number: 1218950-2019-06484
• Device Sequence Number: 1
• Product Code: MHX
• 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,Followup
• Report Date: 08/08/2019

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: 08/08/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 08/08/2019
• Supplement Dates FDA Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• 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): Life Threatening
• Patient Age: 75 YR
• Patient Weight: 98