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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESA UNITS Back to Search Results
Catalog Number 8603800
Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Patient Problem Insufficient Information (4580)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
 
Event Description
It was reported that the device posted a gas mixer and o2 failure and completely shut off during a case.No injury reported.
 
Manufacturer Narrative
The log file was analyzed whereby it was determined that the device passed the automatic power-on self-test (post) in the morning of the date of event without deviations.The respective surgical procedure was started in manual ventilation.Immediately after switchover to volume mode the self-monitoring function detected a communication problem between the cpu board that controls the gas dosage and the user interface.In a situation where ventilator and gas mixer enter a fail state simultaneously the supervisor software routine is designed to switch-off both subsystems.The device went into the so-called "safety mode" and alerted the user to this condition by means of a corresponding alarm.If such deviation occurs during use the user has to set up an adequate oxygen and a-gas flow manually to perform manual ventilation with the in-built breathing bag; monitoring functionalities of the device are not affected by this kind of error condition.The procedure how to establish the emergency gas supply is laid down in the ifu.Dräger knows a certain number of similar events - none of these events could be traced back to a clear root cause.The fact that the identical type of board is used in the workstation twice and does not exhibit malfunctions in the second application periphery makes a general design issue rather unlikely.A reasonable explanation would be electrostatic discharge of the user during interaction with the device or any other kind of electromagnetic disturbance that exceeds the immunity barriers of the device.This is substantiated by the aspect that the communication interrupt occurred immediately after a mode change.The primus was developed in compliance to the requirements of iec 60601-1-2.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported that the device posted a gas mixer and o2 failure and completely shut off during a case.No injury reported.
 
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Brand Name
PRIMUS
Type of Device
ANESTHESA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
MDR Report Key12317721
MDR Text Key268020778
Report Number9611500-2021-00346
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K04207
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 09/23/2021
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 Number8603800
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/13/2021
Supplement Dates Manufacturer Received09/12/2021
Supplement Dates FDA Received09/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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