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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEMS
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DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEMS Back to Search Results
Device Problems Use of Incorrect Control/Treatment Settings (1126); Disconnection (1171); No Audible Prompt/Feedback (2282); Output Problem (3005); Audible Prompt/Feedback Problem (4020)
Patient Problem Bradycardia (1751)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of this investigation.
 
Event Description
It was reported that on (b)(6) 2020 around 12:35 am, the evita v300 ventilator alarmed for disconnection of the breathing hose.The evita v300 was connected to an infinity delta monitor via mib and the ventilation parameters are displayed on the infinity central station (ics).The v300 alarm was not displayed or sounded at the ics because the alarm function setting for external devices was set to off.Therefore, the staff was not informed until the patient became bradycardic and both the delta monitor/ics alarmed for this life-threatening situation.Then the staff switched on the alarm for external devices at the ics to resolve the issue.
 
Manufacturer Narrative
Additional information was provided from the customer stating that the patient was in a coma before and still is.Clinically his condition has not changed (due to the event).Additionally measures (medication.) were not necessary.There was no allegation of a draeger device malfunction for this event.The v300 breathing hose disconnection alarm was not provided at the ics due to a user error where the ics setting for alarm function for external devices was set to off.
 
Event Description
It was reported that on (b)(6) 2020 around 12:35 am, the evita v300 ventilator alarmed for disconnection of the breathing hose.The evita v300 was connected to an infinity delta monitor via mib and the ventilation parameters are displayed on the infinity central station (ics).The v300 alarm was not displayed or sounded at the ics because the alarm function setting for external devices was set to off.Therefore, the staff was not informed until the patient became bradycardic and both the delta monitor/ics alarmed for this life-threatening situation.Then the staff switched on the alarm for external devices at the ics to resolve the issue.
 
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Brand Name
INFINITY CENTRAL STATION
Type of Device
PHYSIOLOGICAL MONITORING SYSTEMS
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC
6 tech drive
andover MA 01810 2434
MDR Report Key10810341
MDR Text Key215330273
Report Number1220063-2020-00014
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
PMA/PMN Number
K061379
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 11/09/2020
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/09/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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