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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
Catalog Number MK06000
Device Problems Circuit Failure (1089); Gas Output Problem (1266); Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2020
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 on (b)(6) 2020 around 7:00 pm the unit was being used on a patient and that it came up with a turbo vent failure.The case was finished by bagging the patient.No patient injury reported.
 
Manufacturer Narrative
The device log file analysis revealed that on the reported date of event a signal failure of the control responsible for the motor speed and motor direction occurred.The signal was not transmitted correctly leading to the reported turbo vent failure.The device has reacted on the detected deviation as specified by posting a corresponding alarm.In this case automatic ventilation is no longer possible.Fresh gas and manual ventilation remain available.The suspected blower pcb was provided for investigation and was assembled in a lab device.The reported symptom could be reproduced and the blower control was found to be faulty.A detailed investigation of the board revealed a faulty digital isolator to be root cause.Replacement of the respective pcb has solved the issue.The device was tested and was returned to use without further problems reported.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 on (b)(6) 2020 around 7:00 pm the unit was being used on a patient and that it came up with a turbo vent failure.The case was finished by bagging the patient.No patient injury reported.
 
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Brand Name
PERSEUS
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key10717416
MDR Text Key212469081
Report Number9611500-2020-00370
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675253600
UDI-Public(01)04048675253600(11)181220(17)190806(93)MK06000-35
Combination Product (y/n)N
PMA/PMN Number
K133886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 12/03/2020
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 NumberMK06000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/01/2020
Initial Date FDA Received10/22/2020
Supplement Dates Manufacturer Received11/04/2020
Supplement Dates FDA Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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