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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 Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2022
Event Type  malfunction  
Event Description
It was reported that a ventilator failure occurred during use. As per report, this did not lead to any consequences for the patient.
 
Manufacturer Narrative
The reported event can be confirmed upon log file evaluation - the recorded error codes indicate that the supervisor function of the software initiated a shutdown of automatic ventilation because the ventilator piston has reached the end position at a time it should not. The piston hub is an equivalent to the volume the ventilator applies and, to protect from potentially hazardous output and/or from serious damages to the ventilator unit the device is designed to shut down automatic ventilation and to post a corresponding alarm; manual ventilation is further available as well as the monitoring functions of the device are. The triggering condition for the error is either to be associated with the motor itself or with the position detection system. The involved device is almost 12 years old, it cannot be excluded that wear and tear of the motor has resulted in speed fluctuations and thus, to a divergence between calculated and measured piston position. On the other hand, it would be imaginable that dust particles on the encoder disc may have disturbed the optical position detection. The local s&s organization will be advised to replace the entire ventilator unit including position detection system to put back the device into fully operable condition. Dräger finally concludes that the device behaved as designed for this specific error condition; the issue does not incorporate a previously unidentified or falsely assessed risk.
 
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Brand NamePRIMUS
Type of DeviceANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key14786240
MDR Text Key297604196
Report Number9611500-2022-00156
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 User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8603800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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