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

Catalog Number 8417801

Device Problems Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

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 shut down during operation.The user removed the device from the patient and used another device.No patient injury reported.

Event Description

It was reported that the device shut down during operation.The user removed the device from the patient and used another device.No patient injury reported.

Manufacturer Narrative

For the investigation the description of event, the provided information and the device logfile had been analyzed.According to the log entries the device detected an overtemperature or overvoltage and generated several times the corresponding alarm.However, the root cause for the overtemperature or overvoltage could not be determined during the investigation.If the savina 300 is not connected to mains power or the power supply detects an overtemperature or an overvoltage, the device switches to the internal battery with audible alarm and the display message "internal battery activated" occurs.The power source switching from ac mains to internal battery was done by the device as specified in the described event.In case of detected overtemperature or overvoltage the internal battery will not be charged because charging is not possible during overtemperature or overvoltage (external sources will be switched off in these cases).This could be seen in the provided logfile.During the discharging process savina indicates corresponding alarm messages from ¿int.Battery activated¿ via ¿int.Battery low¿ to ¿int.Batt.Almost discharged¿.If the battery is discharged, the system shuts down and generates an acoustical power supply failure alarm.In case a ventilation is active at that time, the pneumatic system will open which reduces airway pressure to ambient pressure and spontaneous breathing would be possible for the patient.In the reported event the device generated several times the corresponding overvoltage / overtemperature alarm and the ¿battery could not charge" alarm.Based on the logfile review the device has performed a shutdown due to the total depleted internal battery.There was no patient injury reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 11587409
• MDR Text Key: 249976179
• Report Number: 9611500-2021-00135
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• 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?: Yes
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.