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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC; VENTILATORS, INTENSIVE CARE

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DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC; VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8416400
Device Problems Complete Blockage (1094); Gas Output Problem (1266); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 02/04/2021
Event Type  Death  
Manufacturer Narrative
The investigation has been started.Unfortunately the logbook of the affected device have not yet been made available to the manufacturer.Therefore the information for investigation is very limited.Investigation results will be provide in a final report.
 
Event Description
The customer reported that a patient died during the ventilation.The log file showed that exp.Resistance high were frequently recorded.
 
Manufacturer Narrative
The investigation was based on the reported event, correspondence and enhanced information.The logbook was sent later.The case was initially reported to the appropriate authorities because an adverse event with cause of death of a covid patient was notified.The analysis of the provided log file has shown that the ventilation was started on (b)(6) 2021 at 1:23 pm.On (b)(6) 2021 at 8:58 pm the device posted during the evening several alarm messages concerning "peep high" and "peep low".The user started several suction maneuvers at 9:07 pm, 10:47 pm, 11:27 pm, 11:35 pm and 11:43 pm.At 11:55 pm the user switched the device into standby mode.The log file confirmed peep related alarms on the date of event.A high peep could cause e.G.By the patient condition or obstructions in breathing circuit (blocked filter or fluid in breathing circuit).Fluid in breathing circuit corresponds with the several suction maneuvers which were performed on (b)(6) 2021.The device reacted like specified to a detected difference between the set and measured peep and posted accompanying alarm messages.The log file analysis did not reveal a device malfunction.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects high peep audible alarms would be posted to inform the user about the problem.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.
 
Event Description
The customer reported that a patient died during the ventilation.The log file showed that exp.Resistance high were frequently recorded.
 
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Brand Name
INFINITY ACS WORKSTATION CC
Type of Device
VENTILATORS, INTENSIVE CARE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key11320525
MDR Text Key231561209
Report Number9611500-2021-00059
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K093633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 03/30/2021
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
Device Catalogue Number8416400
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/05/2021
Initial Date FDA Received02/12/2021
Supplement Dates Manufacturer Received03/26/2021
Supplement Dates FDA Received03/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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