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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 07/01/2022
Event Type  malfunction  
Event Description
It was reported during a case that the unit alarmed for a ventilator failure. The patient was manually ventilated and there was no patient injury reported.
 
Manufacturer Narrative
Based on the analysis of the device logfile, the case could be reconstructed. It was found that the device forced a shutdown of automatic ventilation due to a detected wrong motor position. The motor speed is being monitored continuously; speed fluctuations caused e. G. By an abraded collector disc will result in a deviation between measured and expected piston position. To prevent from damages, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm. 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; no patient consequences have been reported. The replacement of the motor assembly ¿ during on-site checking in follow-up to the event by the draeger technician ¿ has already solved the problem. After replacement, the device passed testing and was returned back to use with no 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.
 
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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 Key14983998
MDR Text Key299405502
Report Number9611500-2022-00164
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 07/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8606500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/31/2008
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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