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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS IE; ANESTHESIA UNITS

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DRÄGERWERK AG & CO. KGAA PRIMUS IE; ANESTHESIA UNITS Back to Search Results
Catalog Number 8607500
Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2019
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 the ventilator failed during use.There was no injury reported.
 
Event Description
Please refer to initial mfr.Report #9611500-2019-00423.
 
Manufacturer Narrative
A dräger service engineer was examining the device on-site.The reported issue of ventilator failure could be confirmed; the entire motor assembly was replaced which has put back the device into fully operable condition.The log file evaluation provided by the manufacturer confirms the results obtained on-site.The issue is known from earlier reported instances of the same nature.Root cause for the ventilator failure is wear and tear at the collector disc of the motor which led to partly disrupted electrical contact to the carbon brushes resulting in fluctuations in rotating speed.The supervisor function of the device monitors the motor speed continuously and compares the expected piston position with the one derived by the encoder check.If deviations are detected the device will force a shutdown of automatic ventilation to prevent from damages to the ventilator unit.This is accompanied by a corresponding alarm; manual ventilation as well as the monitoring functions remain available.No patient consequences have occurred and dräger finally concludes that the primus workstation responded as designed upon the malfunction of a single component that became worn after approx.Eleven years of operation.In comparison to the specified lifetime of ten years this can be considered acceptable especially when reflecting that the use model for calculation (5 hours/day & 5 days per week) equals to 13.000 hours in ten years while the operation hours counter for particular motor indicates that it was run for 13.700 hours - 105% of the specified lifetime.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
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Brand Name
PRIMUS IE
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key9443608
MDR Text Key175270866
Report Number9611500-2019-00423
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042419
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 01/13/2020
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 Number8607500
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/12/2019
Initial Date FDA Received12/10/2019
Supplement Dates Manufacturer Received12/03/2019
Supplement Dates FDA Received01/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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