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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA APOLLO; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA APOLLO; ANESTHESIA UNITS Back to Search Results
Catalog Number 8606500
Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2021
Event Type  malfunction  
Manufacturer Narrative
The ventilator failure described by the user could be reconstructed by means of the logfile analysis.No indications for a device malfunction were found.The autonomous safety shutdown of the ventilator was triggered by a too fast and too high pressure increase, possibly due to the patient breathing or coughing against the ventilator.The device behaved as specified with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.At the time in question, the volume af mode was used; in general, it is recommended to switch on the synchronization for spontaneously breathing patients (e.G.Volume af mode with activated trigger) or use synchronized ventilation mode (e.G.Pressure support).The device behaved as specified with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.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 during the beginning of a case the patient had coughed causing the unit to have a ventilator failure message.The unit was swapped out and the case was completed.There was no patient injury reported.
 
Event Description
It was reported during the beginning of a case the patient had coughed causing the unit to have a ventilator failure message.The unit was swapped out and the case was completed.There was no patient 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
APOLLO
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
MDR Report Key12419812
MDR Text Key271311991
Report Number9611500-2021-00364
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 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8606500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2012
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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