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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS INTELLIVUE INFORMATION CENTER IX; CENTRAL STATION MONITOR Back to Search Results
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.
 
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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 Key8939620
MDR Text Key155846144
Report Number1218950-2019-06484
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102495
Number of Events Reported1
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 Number866389
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 Received08/28/2019
Supplement Dates Manufacturer Received08/08/2019
Supplement Dates FDA Received09/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age75 YR
Patient Weight98
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