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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 Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2022
Event Type  malfunction  
Manufacturer Narrative
The device was subject to an on-site check by the dispatched dräger service engineer who confirmed the reported ventilator failure upon log file review. The error condition could be traced back to the ventilator motor. The ventilator motor assembly was replaced, consequently. The device passed all consecutive tests and was returned to use. Evaluation of earlier reported similar events revealed that wear-and-tear related abrasion of the collector disc had resulted in development of positions where the motor does not provide mechanic power due to contact interrupts to the carbon brushes; speed fluctuations will be the consequence. The speed fluctuations result in a deviation between measured and expected piston position. The piston hub defines the applied tidal volume and thus, to prevent from potentially hazardous output and/or from damages to the ventilator unit, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm. As confirmed for the particular case, manual ventilation and the monitoring functions remain available to the full extent. Dräger finally concludes that the device behaved as specified upon the malfunction of a single component after 15 years of use; no patient consequences have been reported. The repair exchange had fully solved the device problem. 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 there was a ventilator failure during use and that only manual ventilation was available. There was no patient injury reported.
 
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Brand NameAPOLLO
Type of DeviceANESTHESIA 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 Key14840997
MDR Text Key297588405
Report Number9611500-2022-00125
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
Report Date 06/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8606500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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