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

Catalog Number 8417800

Device Problems Display or Visual Feedback Problem (1184); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2018

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 rebooted continuously with device failure 83.0008 message on the screen while in use on patient.Thus, the customer powered off and replaced the device.After starting up the device again the symptom could not be reproduced.No injury has been reported.

Event Description

Please refer to the initial report.

Manufacturer Narrative

The log file of the affected device was provided for the investigation.It could be confirmed that the device performed multiple warmstarts on the reported date of event.Based on the error code df40.2000 the warmstarts occurred due to a missing power source.However, the reported device failure 83.0008 was not stored on the log file.Based on the log entries the batteries were checked onsite without finding any deviation and the power supply was replaced and sent to the manufacturer for a detailed analysis.No failure of the power supply could be detected during a 24 hour test in a laboratory savina 300 device.Therefore, the root cause for the missing power source could not be determined.The device reacted as specified to a deviation within the power source by initiating a software-controlled reboot (warmstart) in an attempt to solve the issue.A warmstart is accompanied by an audible and visible alarm of high priority and the pneumatic system opens which reduces airway pressure to ambient pressure allowing for spontaneous breathing.In case the deviation cannot be remedied by multiple warmstarts, the ifu advises the user to continue ventilation without delay using another independent ventilator.The user further reported occurrences of the device failure 43.0120 which could also be found in the log file in 2017 and has not occurred since.However, this device failure is not related to the reported event.

• 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: 8004506
• MDR Text Key: 125280370
• Report Number: 9611500-2018-00340
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)160905(17)160905(93)8417800-26
• Combination Product (y/n): N
• PMA/PMN Number: K121886
• 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: 11/26/2018

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 Expiration Date: 11/23/2018
• Device Catalogue Number: 8417800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1