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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA PERSEUS; ANESTHESIA UNITS Back to Search Results
Model Number MK06000
Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2023
Event Type  malfunction  
Event Description
It was reported that the anesthesia workstation shut itself off.Reportedly, patient support was bridged manually; the device was turned back on and, the procedure could be finished w/o further complications.It was explicitly mentioned that the issue did not result in consequences for the patient.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Manufacturer Narrative
The device was checked by a dräger service engineer who performed an initial review of the log file and replaced the circuit board that controls the therapy functions as well as a memory (cf) card.The device passed all consecutive test and could be returned to use.A detailed log file analysis was provided by the manufacturer; the reported issue could be reconstructed.The ventilation of the concerned procedure went stable and uneventful for the first two hours until the therapy control unit performed a reboot to overcome a deviation in the sw processing.The reboot was successfully completed after 13 seconds and, the device resumed ventilation with previous settings.The user shortly switched to standby and was then using an automatic ventilation mode for a further hour without additional issues.The replaced board was checked in the manufacturer's lab but.No hardware issue could be identified; the root cause for the deviation in the sw processing could not be determined.The log did not contain further instances of this failure.Dräger finally concludes that the device responded as designed upon a deviation of unknown origin; a reboot was initiated to set all sw processes back to a controlled state, the user was alerted to the reboot by means of a corresponding alarm and, therapy was continued afterwards with the latest valid settings.
 
Event Description
It was reported that the anesthesia workstation shut itself off.Reportedly, patient support was bridged manually; the device was turned back on and, the procedure could be finished w/o further complications.It was explicitly mentioned that the issue did not result in consequences for the patient.
 
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Brand Name
PERSEUS
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 Key16493668
MDR Text Key310821855
Report Number9611500-2023-00086
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675253600
UDI-Public(01)04048675253600(11)210707(17)220214(93)MK06000-39
Combination Product (y/n)N
PMA/PMN Number
K133886
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 04/04/2023
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 Model NumberMK06000
Device Catalogue NumberMK06000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/07/2023
Initial Date FDA Received03/07/2023
Supplement Dates Manufacturer Received03/27/2023
Supplement Dates FDA Received04/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2021
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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