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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 Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2023
Event Type  malfunction  
Event Description
It was reported that the device suddenly posted an alarm during use and shut down automatic ventilation.There was no detail in the report which would reasonably suggest that consequences to the patient have occurred.
 
Manufacturer Narrative
The evaluation has just started; results will be provided in a follow-up report.H3 other text : ongoing.
 
Manufacturer Narrative
A dräger service engineer has examined the device on-site.Log file review showed that the device must have been used further since the entries for the period in question were overwritten with newer data already.Among this newer data further entries indicating a safety shut-down of automatic ventilation can be found whereupon the reported issue could be confirmed.The engineer has run the automatic power-on self-test which has not been completed successfully; the section for the ventilator referentiation was not passed.The board which controls the ventilator supervision functions as well as the ventilator motor were replaced as a precautionary measure; the device passed all tests afterwards and was returned to use.The parts were returned to the manufacturer for evaluation and installed into the periphery of a lab device, the reported issue however could not be duplicated.A safety shut-down of automatic ventilation may be forced by the system autonomously to protect the patient from potentially hazardous output.The triggering conditions may be multiple and are not necessarily related to malfunctions.For example, if the patient is coughing against a piston hub applied by the ventilator, this may result in a fast and high rise of the airway pressure upon which the system reacts with a shut-down of automatic ventilation.If the sensor that monitors the airway pressure fails or if the piston position detection system is errorneous, ventilation will be shut-down as well.The shut-down is accompanied by a corresponding alarm; manual ventilation including gas dosage and the monitoring functionalities remain unaffected.Dräger concludes that the device responded as designed upon a deviation of unknown origin; the exact rigger for the safety shut-down could not be determined.A sporadic malfunction of the cylinder pressure sensor due to ingress of humidity would be a plausible explanation; the humidity will evaporate over time and the effects are not present anymore in later evaluations.
 
Event Description
It was reported that the device suddenly posted an alarm during use and shut down automatic ventilation.There was no detail in the report which would reasonably suggest that consequences to the patient have occurred.
 
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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
GM 
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
Manufacturer Contact
moislinger allee 53-55
lübeck 23542
4518822868
MDR Report Key17077163
MDR Text Key316683531
Report Number9611500-2023-00210
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 07/07/2023
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? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/17/2023
Initial Date FDA Received06/07/2023
Supplement Dates Manufacturer Received06/27/2023
Supplement Dates FDA Received07/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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