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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 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 02/25/2021
Event Type  Malfunction  
Manufacturer Narrative

Savina 300 asmb-0153 was produced in february 2019. Based on the investigation, the reported case including correspondence and its logbook were analyzed. On site, the device was examined by a dräger service technician. Based on the logbook, a failure of the device could be confirmed. The reason for the failure was the completely worn out or defective internal batteries with a greatly reduced runtime. However, the device did alarm, contrary to what was reported. In this case, the time between the alarms "internal battery low" and "internal battery discharged" was only a few seconds, after which the device went off. The audible low voltage alarm that followed the shutdown due to voltage loss sounded for at least 2 minutes, so the device behaved as specified. During the discharge process, successive alarm messages from "int. Battery activated "to "int. Battery low" to " int. Battery discharged " are displayed with increasing priority to inform the user of the status. When the battery is completely discharged, the unit will shut down and an audible power failure alarm will be generated for at least 2 minutes. If ventilation is active at this time, the pneumatic system will open, reducing airway pressure to ambient and allowing the patient to breathe spontaneously. It is recommended by the manufacturer to replace the internal batteries at least every 2 years. We assume that the batteries from the ventilator produced in feb 2019 have not yet been considered in any replacement interval. A replacement of these internal batteries has now been performed by the service technician on site. The device has been tested according to manufacturer specifications and has not indicated any other deviations or abnormalities. The use of the external battery option is recommended for the intra-hospital transport use case. The risk assessment related to the reported event does not reveal any new or additional risk with respect to the known risks at the time of product development, during the product improvement process, or risks to be expected in the course of use in accordance with the intended purpose, consequently this event is to be considered as within the device safety concept. The failure rate of the internal batteries in the field is observed and considered unremarkable.

 
Event Description

It has been reported that the device has stopped ventilating due to discharge of the battery without prior alarm. No patient health consequences were reported.

 
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Brand NameSAVINA 300
Type of DeviceVENTILATORS, INTENSIVE CARE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key11515648
MDR Text Key251661089
Report Number9611500-2021-00114
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
PMA/PMN NumberK180779
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Type of Report Initial
Report Date 03/18/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/18/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8417800
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/28/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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