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

Catalog Number 8417800

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 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

The device was in operation for approximately seven years now and is not under a service contract.Thus, the user facility did not involve the local dräger s&s organization in examination and repair of the device.The biomedical department of the hospital was contacted by dräger and, one detail in the report from the user must be revised upon the feedback: the device did not shut down as initially reported but performed a restart.No further information in regard to diagnosis or repair measures were made available.The lack of information does only allow a general assessment and no case-specific evaluation.A restart is the specified device behavior to remove error conditions that can't rectified by other means.The device will briefly power off to set all running software processes back to a controlled state.During the reboot sequences which lasts 12 seconds at the utmost the device will open the pneumatic system to ambient to allow spontaneous breathing and, the device will post a corresponding alarm to alert the user.It the reboot was successful ventilation will be resumed with latest settings, automatically.It is in the nature of things that disturbances in the software processing can likely be corrected by a reboot but hardware errors are rather still persisting afterwards.Without access to the logfile or to the device it is impossible to draw a reliable conclusion in regard to the triggering condition for the reboot.However, based on experience with devices for which a hospital performs preventive service and maintenance on own behalf and responsibility, a worn internal battery may be the root cause for the reboot.It is recommended to check the internal battery in regular intervals and to replace it every two years depending on the number of use cycles it was subject to.If this is not done, the regular battery status check the device performs autonomously can fail and, a device restart is the consequence.The ifu clearly explains that the daily pre-use check shall include a manual test step in which the user has to disconnect the device from mains supply to verify that the device can run on battery power.This test is able to identify a worn battery.Device not available for evaluation.

Event Description

It was reported that a shut-down of the device occurred during a running ventilation episode.The device was replaced in a controlled maneuver; no patient consequences have reportedly occurred.

• Brand Name: SAVINA 300
• Type of Device: VENTILATORS, 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 Key: 15825307
• MDR Text Key: 307711076
• Report Number: 9611500-2022-00314
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)151106(17)170529(93)8417800-23
• Combination Product (y/n): N
• PMA/PMN Number: K180779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2022

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 Number: 8417800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2015
• 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
• Treatment: NA.