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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); Output Problem (3005); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2022
Event Type  malfunction  
Event Description
It was reported that during the running condition suddenly machine gives alarm of gas mixer after that it shows ventilator fail alarm. Machine stopped the ventilation.
 
Manufacturer Narrative
The investigtion was just started, the result will be forwarded after closing the investigation.
 
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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 Key14236305
MDR Text Key297349373
Report Number9611500-2022-00106
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8603800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2013
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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