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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA CARINA; VENTILATORS, OTHER
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DRÄGERWERK AG & CO. KGAA CARINA; VENTILATORS, OTHER Back to Search Results
Catalog Number 8419350
Device Problem Occlusion Within Device (1423)
Patient Problems Cyanosis (1798); Low Oxygen Saturation (2477)
Event Date 04/02/2018
Event Type  Injury  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow up-report.
 
Event Description
It was reported that during use the patient¿s sputum occluded the leak valve of the device.As a result the patient¿s spo2 decreased and the patient suffered cyanosis.After replacement of the circuit the patient recovered.
 
Event Description
Please refer to the initial-report.
 
Manufacturer Narrative
The affected device was checked by dräger service on-site and no malfunction could be found.The log file was sent to the manufacturer for detailed investigation.Based on the log entries the device generated the visual and audible alarm ¿leakage valve blocked¿ three times around the reported time of the event.There are no log entries indicating a device malfunction.It can be concluded that the device reacted as specified to an occluded leak valve by generating the corresponding alarm.No device malfunction could be detected.
 
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Brand Name
CARINA
Type of Device
VENTILATORS, OTHER
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key7424652
MDR Text Key105251449
Report Number9611500-2018-00101
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K072885
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 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2000
Device Catalogue Number8419350
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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