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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 Decrease in Pressure (1490); Failure to Deliver (2338); Inaccurate Delivery (2339); Gas/Air Leak (2946)
Patient Problem Low Oxygen Saturation (2477)
Event Date 07/31/2021
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 machine could not generate the tidal volumes that were set on the ventilator.No adequate manual ventilation of the patient possible.Ambu bag was used to ventilate the patient.The patient was getting a mandibular fixation, and the surgery was stopped to do this.The patient desaturated to the 50's and it was decided to orally intubate the patient.Subsequently, the patient was transferred to the icu as a continued intermittently desaturation due to tube exchange was observed.
 
Manufacturer Narrative
The device was checked in follow-up of the event by a dräger service engineer.The error condition could not be duplicated.Since it was stated that the device wouldn¿t have alarmed, especially the alarm functionality was tested in cooperation with the hospital¿s biomed.It was found working according to specifications; all provoked alarm conditions triggered the expected alarms.Evaluation of the log file made by the manufacturer confirms the on-site expertise in every detail.The records therein indicate that the device passed the system test in the morning of the doe without deviations.Just from the beginning of automatic ventilation in the concerned procedure the device alarmed for apnea, mv low and inspiratory tidal volume high indicating the presence of a significant circuit leak.This leakage was not removed and thus, it was finally leading to a fresh gas deficit; the corresponding fresh gas low or leakage alarm was posted.The device was set to standby mode for a few minutes then.The user initiated a new instance of the breathing system test which was passed.Most probably, the patient circuit has been replaced before this test as it was mentioned as a side note in the user¿s report.Afterwards the procedure was continued for more than 2 hours with stable and unremarkable ventilation towards the end.All in all, no indication for the potential presence of a device malfunction could be found.The reported symptom was most likely caused by a significant circuit leaks outside the device leading to a loss of pressure, volume and fresh gas.Dräger finally concludes that the device issued appropriate alarms to call the attention of the user.All alarms, possible causes as well as remedies are described in the instructions for use.
 
Event Description
It was reported that the machine could not generate the tidal volumes that were set on the ventilator.No adequate manual ventilation of the patient possible.Ambu bag was used to ventilate the patient.The patient was getting a mandibular fixation, and the surgery was stopped to do this.The patient desaturated to the 50's and it was decided to orally intubate the patient.Subsequently, the patient was transferred to the icu as a continued intermittently desaturation due to tube exchange was observed.
 
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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 
MDR Report Key12317594
MDR Text Key268020874
Report Number9611500-2021-00344
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K133886
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 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
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
Date Manufacturer Received09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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