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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 Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2024
Event Type  malfunction  
Event Description
It was reported that during an operative case the atlan power cord was dislodged causing the anesthesia machine to full turn off.This resulted in the patient having a loss of ventilation until manual ventilation could occur via an emergency circuit from wall oxygen.No injury reported.
 
Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
 
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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 Key18854145
MDR Text Key337693361
Report Number9611500-2024-00097
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675556176
UDI-Public(01)04048675556176(11)200720(93)8621500-08
Combination Product (y/n)N
PMA/PMN Number
K0230931
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2024
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 Received02/08/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/20/2020
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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