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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ATLAN A350; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA ATLAN A350; ANESTHESIA UNITS Back to Search Results
Catalog Number 8621500
Device Problems No Device Output (1435); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
Event Description
It was reported that the device had switched itself off during an ongoing anesthetic.It was not possible to restart it.The screen remained dark.The emergency oxygen supply continued to function so that the operation could be completed using the bag.No patient injury reported.
 
Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
 
Manufacturer Narrative
An analysis of the device logbook for the period in question shows that the device switched off on 18.01.24 at 09:07.A cause for the switch-off could not be found on the basis of the log recordings.The omniboard and the m48 processor board were replaced on site.The analysis of the components received showed that the omniboard was functioning correctly, but the processor board could be identified as the cause of the reported symptoms.If the processor board is faulty, the device issues an alarm and stops automatic ventilation.In this case, the patient can continue to be ventilated in manual emergency mode or with an emergency manual ventilation bag.As initially reported, the emergency oxygen supply continued to work so that the operation could be completed with the bag.After replacing the components mentioned, no further abnormalities were detected.The field failure rate was assessed as acceptable.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 the device had switched itself off during an ongoing anesthetic.It was not possible to restart it.The screen remained dark.The emergency oxygen supply continued to function so that the operation could be completed using the bag.No patient injury reported.
 
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Brand Name
ATLAN A350
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 Key18604934
MDR Text Key334025751
Report Number9611500-2024-00028
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675556176
UDI-Public(01)04048675556176(11)200630(93)8621500-08
Combination Product (y/n)N
PMA/PMN Number
K230931
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 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8621500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2020
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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