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

Catalog Number 8417800

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Inappropriate or Unexpected Reset (2959)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2017

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 during use the user tried to change the ventilation, the screen froze and the system rebooted.After the reboot, the system worked properly.No injury reported.

Manufacturer Narrative

The log files of the affected device were provided for investigation.Log analysis revealed that on the reported date of event a ventilator reboot was logged.The logged error codes reveal a technical deviation within the electronic system which caused a software controlled restart as a specified reaction in order to solve the deviation.In this case, the pneumatic system opens which reduces airway pressure to ambient pressure and spontaneous breathing is possible for the patient.This system reset is combined with an audible and visible alarm of high priority.After termination of the restart procedure (max.12 sec), ventilation was continued with the latest settings which was confirmed by user log recording.

Event Description

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
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 7036423
• MDR Text Key: 93170040
• Report Number: 9611500-2017-00344
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8417800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1