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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS INFINITY EMPOWERED; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA PRIMUS INFINITY EMPOWERED; ANESTHESIA UNITS Back to Search Results
Catalog Number 8607500
Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Patient Problem Unspecified Blood or Lymphatic problem (4434)
Event Date 03/04/2024
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 about 3 hours after the surgery started, co2 alarm and apnea alarm occurred and mechanical ventilation stopped.All buttons on the control panel no longer worked.The patient was immediately removed from the anesthesia device and connected to another anesthesia device, then the surgery was continued.
 
Event Description
It was reported that about 3 hours after the surgery started, co2 alarm and apnea alarm occurred and mechanical ventilation stopped.All buttons on the control panel no longer worked.The patient was immediately removed from the anesthesia device and connected to another anesthesia device, then the surgery was continued.
 
Manufacturer Narrative
The investigation was performed based on the analysis of replaced pcb mobi (monitor control panel) as the log could not be downloaded.The board was installed in a laboratory device.The described observations of the service technician that the boot process stopped and a running man was visible could be reproduced.For a similar circuit board both controllers were artificially reset.As a consequence automatic ventilation was stopped while switching mode to man/spont accompanied by an acoustical alarm given via the secondary piezo signal generator of the power supply.Without evaluation of the log file the exact root cause could not be determined.It is possible that invalid data in the ram memory of the controller has caused the failure.The device has behaved as specified by stopping the automatic ventilation and posting an alarm to inform the user about the situation.In this case manual ventilation- using emergency o2 dosing (also in combination with volatile anesthetics) and an adequate apl valve position- is still available and can be used to continue the procedure.As no further reports have been received it can be concluded that replacement of the pcb mobi has solved the issue.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.
 
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Brand Name
PRIMUS INFINITY EMPOWERED
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 Key18920041
MDR Text Key337846421
Report Number9611500-2024-00116
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,Followup
Report Date 05/07/2024
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? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/04/2024
Initial Date FDA Received03/18/2024
Supplement Dates Manufacturer Received05/03/2024
Supplement Dates FDA Received05/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.; NA.
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