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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 Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2023
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
 
Event Description
It was reported that there was a vent fail during use.There was no patient injury reported.
 
Manufacturer Narrative
The log file was available for investigation.It revealed, that the vent failure occurred, after a leak test, during switch to standby and not, during use on a patient as reported.The ventilator detected a wrong motor position (code 14.1499) and forced an autonomous shutdown to safety mode.The appropriate ventilator fail alarm was given.Manual ventilation remained available, as specified.During inspection, the light barrier cable was found to be faulty.The cable was replaced.The device reacted as specified with an autonomous shutdown of the ventilator and alarmed audible and visible for ventilator fail.Manual ventilation remained available, as specified.
 
Event Description
It was reported, that there was a vent fail, during use.There was no patient injury reported.
 
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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
Manufacturer Contact
moislinger allee 53-55
lübeck 23542
4518822868
MDR Report Key17822849
MDR Text Key324327730
Report Number9611500-2023-00338
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675229674
UDI-Public(01)04048675229674(11)210531(17)250605(93)8606500-68
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 11/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 09/01/2023
Initial Date FDA Received09/27/2023
Supplement Dates Manufacturer Received11/01/2023
Supplement Dates FDA Received11/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2021
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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