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

Catalog Number 8414450

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

When creating the follow-up report for this incident it was found that the initial report was not submitted correctly due to a duplicate error.Therefore, we are resending this as an initial report.Initial analysis of the reported observations led to the conclusion that a causal connection to the controller board of the device is likely.The particular pcb was replaced, the device passed all consecutive tests and is back in use w/o further problems reported since then.The error condition could be provoked in the lab with a specific software which generates a multitude of read-write-operations between the main processor and a dedicated memory chip.One single reboot was the only consequence if the triggering conditions came into effect.A deviation in the electronic system that can't be rectified by sw routines will trigger a restart of the entire system.During the restart sequence which usually does not take longer than 12 seconds the device opens the pneumatic system to ambient to enable spontaneous breathing of the patient.The user will be alerted by means of a corresponding high-priority alarm.After completion of the restart the ventilation will be continued with the last valid settings.The error condition could only be duplicated under exacerbated test conditions i.E.The occurrence rate in the field will be much less in comparison to the conditions used in the lab tests.Investigation of the issue is still ongoing to understand the problem in full level of detail and to define measures that suppress the triggering conditions for the reported single reboots.

Event Description

It was reported that the device restarted, generated an alarm and displayed different error codes during ventilation.No injury was reported.

• Brand Name: SAVINA
• 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: 10498768
• MDR Text Key: 206540145
• Report Number: 9611500-2020-00317
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675016403
• UDI-Public: (01)04048675016403(11)180903(17)210117(93)8414450-47
• Combination Product (y/n): N
• PMA/PMN Number: K003068
• 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: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8414450
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2018
• 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