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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA 300 VENTILATORS, INTENSIVE CARE

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DRÄGERWERK AG & CO. KGAA SAVINA 300 VENTILATORS, INTENSIVE CARE Back to Search Results
Device Problems Gas Output Problem (1266); Failure to Run on Battery (1466); Decrease in Pressure (1490)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2021
Event Type  malfunction  
Manufacturer Narrative
The device was examined by a dräger service engineer whereby it was revealed that the internal battery was out of specification ¿ this has triggered the reported reboot. The savina 300 is equipped with an internal battery that is intended to cover mains power losses or ensure ongoing ventilation during a patient transport. The device software performs a battery test procedure in the background in regular intervals to calculate the battery status and the runtime forecast. If a particular test instance fails due to an outdated or depleted battery this may trigger a reboot of the entire device. During a reboot sequence the airway pressure will be released to ambient and the device posts an alarm to alert the user about the reboot. After a typical period of 12 seconds the reboot will be completed and the device resumes ventilation with previous settings. The batteries shall be inspected on regular base and replaced every two years; a respective statement is laid down in the ifu. The particular device was manufactured in 02/2017 and still equipped with the initial battery installed at the time of manufacture. Dräger finally concludes that the device behaved as specified upon an error condition of a single component. Replacement of the component has fully solved the issue ¿ the device is back in use. No patient consequences have been reported for the particular event.
 
Event Description
It was reported that the device performed a reboot during use. The users were aware that ventilation was continued after a few seconds but have replaced the device in a controlled maneuver in abundance of caution. No patient consequences have occurred.
 
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Brand NameSAVINA 300
Type of DeviceVENTILATORS, INTENSIVE CARE
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 Key12511265
MDR Text Key273816135
Report Number9611500-2021-00395
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K180779
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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