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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA PRIMUS; ANESHESIA UNITS Back to Search Results
Catalog Number 8603800
Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2021
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 during ventilation the device alarmed "ventilator failure.Manual ventilation possible".No injury reported.
 
Event Description
It was reported that during ventilation the device alarmed "ventilator failure.Manual ventilation possible".No injury reported.
 
Manufacturer Narrative
The investigation was carried out based on evaluation of the electronic log file.A sporadic malfunction of a cpu board which controls the device-internal communication between user interface and vgc (ventilation and gas controller) was identified to be root cause of the reported failure.This leads to a shutdown of the ventilator and gas mixer.In this situation, the device automatically switches to monitoring mode while alarming the user to this condition by means of a corresponding alarm.For the actual case, the unit was on standby - a patient was not connected.As described in the ifu manual ventilation with emergency oxygen dosage remains possible including the application of anesthetic gas as well.Dräger finally concludes, that the device has reacted according to its safety concept and has performed an emergency shutdown of the affected components accompanied by the respective alarms.Similar cases are known ¿ however, the exact failure mechanism could not be determined during in-depth analysis.It was only possible to narrow down the root cause to the respective pcb.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.The primus was developed in compliance to the requirements of iec 60601-1-2.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported that during ventilation the device alarmed "ventilator failure.Manual ventilation possible".No injury reported.
 
Manufacturer Narrative
Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.
 
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Brand Name
PRIMUS
Type of Device
ANESHESIA 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 Key12133803
MDR Text Key262887587
Report Number9611500-2021-00295
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,Followup
Report Date 05/31/2022
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/25/2021
Initial Date FDA Received07/08/2021
Supplement Dates Manufacturer Received08/11/2021
08/11/2021
Supplement Dates FDA Received08/26/2021
06/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2007
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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