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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 Gas Output Problem (1266); Sensing Intermittently (1558); Tidal Volume Fluctuations (1634)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that there was wired noise coming out of the flow sensor/expiratory valve area which is likely related to an disturbed ventilation.No patient consequences have been reported.
 
Manufacturer Narrative
The log file of the affected device and provided information built the basis for the investigation.The logged entries indicate a faulty cable harness flow sensor.The cable harness flow sensor is necessary to measure the expiratory flow, which is used for control and monitoring of the ventilation.In case the measurements are adulterated, influence on the ventilation is likely and an exceedance of set alarm limits triggers corresponding visual and audible alarms (e.G.Leakage alarms).In addition, a ¿chattering¿ noise may be observed close to the expiratory valve.However, ventilation does not completely stop.The ifu states as a warning: "if a fault is detected in the medical device, its life-support functions may no longer be assured.Ventilation of the patient using an independent ventilation device must be started without delay, if necessary with peep and/or an increased inspiratory o2 concentration (e.G.With a manual resuscitator)." there were no patient consequences reported.It can be concluded that the device alarmed as specified in order to alert the user to detected deviations.The suspected cable harness flow sensor has been already replaced on site.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported that there was wired noise coming out of the flow sensor/expiratory valve area which is likely related to an disturbed ventilation.No patient consequences have been reported.
 
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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 Key11001685
MDR Text Key221275563
Report Number9611500-2020-00458
Device Sequence Number1
Product Code CBK
UDI-Device Identifier04048675042266
UDI-Public(01)04048675042266(11)160310(17)161124(93)8416400-16
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 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8416400
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/24/2020
Initial Date FDA Received12/14/2020
Supplement Dates Manufacturer Received01/18/2021
Supplement Dates FDA Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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