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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.
 
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
Analysis of the provided log file revealed that the records do not cover the date of event january 23rd 2024.A log file including the date of event was requested but unfortunately was not provided.Therefore, a reconstruction of the case in question was not possible.A check of the available log file did not show any indication for a battey malfunction.During on-site inspection the technician identified that the battery was depleted.We were further informed by the customer that the battery is regularly depleted as the device is moved around and often not connected to mains power.Acc.To the ifu the atlan is not intended to be used for patient transport.Frequent use of the battery and especially recurrrent deep discharges of the battery lead to a premature aging of the battery.To obtain information about the condition of the battery the customer was asked to perform a battery test.Since now we have not received any feedback on this.Finally, due to missing information a clear statement about the root cause of the reported event could not be drawn.In case of a power supply failure or a disconnection of the device from mains supply, the device continues operation using the internal backup batteries without limitation of functionality while a power failure alarm is given.A fully charged battery will maintain operation for at least 45 minutes.The remaining capacity of the batteries is displayed on the status display and additional warnings are given when the residual battery charge is low respectively very low.If mains power supply fails and the battery is discharged, a signal tone is emitted.Manual ventilation and spontaneous breathing are still available as it was reported for the current case.
 
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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
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
Initial Date Manufacturer Received 02/08/2024
Initial Date FDA Received03/07/2024
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
Treatment
NA.; NA.
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