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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNITS Back to Search Results
Catalog Number 8603800
Device Problems Failure to Deliver (2338); No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
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 a ventilator failure.There was no patient injury reported.
 
Event Description
Please refer to the initial-report.
 
Manufacturer Narrative
As neither the electronic device logfile nor the replaced parts were available the evaluation was based on the initially provided information, only.Since it was reported that replacement of the motor assembly has fixed the problem, it was concluded that a failure of one or more of its components has caused the observed failure.However, based on the available information, the exact root cause could not be determined.In case the ventilator fails, the device will generate a corresponding visible and audible ventilator fail alarm.Manual ventilation and monitoring will remain available to continue the case.
 
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Brand Name
PRIMUS
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key9271236
MDR Text Key188215779
Report Number9611500-2019-00367
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042607
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 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8603800
Was Device Available for Evaluation? No
Date Manufacturer Received11/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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