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

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.

• Brand Name: SAVINA 300
• Type of Device: VENTILATORS, 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 Key: 11515648
• MDR Text Key: 251661089
• Report Number: 9611500-2021-00114
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)190226(17)220101(93)8417800-38
• Combination Product (y/n): N
• PMA/PMN Number: K180779
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8417800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1