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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 Analyze Signal (1539); Failure to Deliver (2338)
Patient Problem Insufficient Information (4580)
Event Date 05/04/2022
Event Type  malfunction  
Event Description
During internal review, it was noticed that this case was not reported by the manufacturer. It was reported that a vent fail occured during use. There was no patient injury reported.
 
Manufacturer Narrative
Based on the performed log file analysis, a sporadic failure of the inspiratory pressure sensor of the pcb vgc (ventilation and gas controller) was detected. Consequently, an autonomous shutdown to safety mode was initiated. The corresponding ventilator fail alarm was displayed and an acoustic alarm given. Manual ventilation as well as monitoring function remained possible. Dräger finally concludes that the device reacted as specified upon a sporadic failure of the inspiratory pressure sensor. On-site, in follow-up of the event, the dispatched draeger technician has already replaced the pcb vgc as a precautionary measure. The device was successfully tested afterwards 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.
 
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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 Key15010898
MDR Text Key295888075
Report Number9611500-2022-00170
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 05/19/2022,07/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2022
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
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer05/19/2022
Date Manufacturer Received05/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2017
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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