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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
Catalog Number 8417800
Device Problems Loss of Power (1475); Failure to Deliver (2338); Complete Loss of Power (4015)
Patient Problem Low Oxygen Saturation (2477)
Event Date 10/23/2021
Event Type  Death  
Event Description
It was reported that due to a power outage and depleted batteries the patient needed to be bagged.The patient desaturated and was disconnected from the ventilator for resuscitation purpose.The patient was connected back to the ventilator and the ventilation had continued after the power outage was over.At the moment it is unclear wether the reported device behaviour contributed to the later reported death of the patient.
 
Manufacturer Narrative
The investigation has just started; results will provided in a follow-up report.
 
Event Description
It was reported that due to a power outage and depleted batteries the patient needed to be bagged.The patient desaturated and was disconnected from the ventilator for resuscitation purpose.The patient was connected back to the ventilator and the ventilation had continued after the power outage was over.At the moment it is unclear wether the reported device behaviour contributed to the later reported death of the patient.
 
Manufacturer Narrative
The information provided by the user and the log file of the affected savina with serial number (b)(6) were analyzed for investigation.Based on the log file it can be concluded that the device performed an unexpected warmstart due to a power outage.The log entries indicate that the device alarmed prior to the power outage as specified and the ventilation continued immediately after the return of the ac mains power.No device failure could be seen.If savina 300 is not connected to mains power or ac mains is interrupted, the savina switches to the external battery (if available) and the hint ¿external dc activated¿ is displayed.If the external battery is discharged, a mid-prior alarm message ¿external dc supply failure¿ occurs.Otherwise, if the savina is not equipped with an external battery, the unit switches to the internal battery with audible alarm and the display message "internal battery activated" occurs.Different alarms will indicate the state of the batteries during the discharging process.When the battery is completely discharged, the system shuts down and generates an acoustical power supply failure alarm.The pneumatic system will open which reduces airway pressure to ambient pressure and spontaneous breathing would be possible for the patient.If the ventilator is connected to ac mains again, it will restart immediately, and the ventilation will be continued with the last settings.After the device has been reconnected to the main power it restarted and continued ventilation.In this case the device informed and alerted the user about the remaining run time prior to the power outage and the shut down during the power outage as specified by posting the corresponding alarms.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
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Brand Name
SAVINA 300
Type of Device
VENTILATORS, INTENSIVE CARE
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
MDR Report Key14268479
MDR Text Key290567326
Report Number9611500-2022-00107
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K180779
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,Followup
Report Date 06/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8417800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2013
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.
Patient Outcome(s) Death;
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