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

Catalog Number 8417801

Device Problems Circuit Failure (1089); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem Urinary Retention (2119)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that the device suddenly displayed a black screen and could not be turned on again during use on patient.The device was immediately replaced.No consequences to the patient were reported.

Manufacturer Narrative

The affected device was repaired by a third-party company and dräger was informed about the results.A log file was provided for analysis.However, the reported date of event was no longer included in the log entries as they were overwritten by new entries during further usage.The replaced part was not available for analysis.Based on the reported information the problem was fixed by replacing the pcb ccb-ii.A failure of this pcb could lead to the reported failure.However, due to the insufficient information the root cause could not be confirmed.In case of a significant deviation within the electronic system the device will perform a restart of the whole electronic system in an attempt to solve the issue.The restart is combined with an audible and visible alarm of high priority and the device opens the pneumatic system to allow for spontaneous breathing.If the failure is irreversible, the startup sequence cannot be finished resulting in a continued high priority audible alarm.In this case, the ifu describes that the customer has to disconnect the patient from the device and continue ventilation without delay using another independent ventilator.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Event Description

Please refer to the initial report.

• 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
• MDR Report Key: 10217193
• MDR Text Key: 197100051
• Report Number: 9611500-2020-00221
• Device Sequence Number: 1
• Product Code: CBK
• 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,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8417801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1