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

Catalog Number 8417800

Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)

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

Event Date 03/24/2021

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 only works for 8 minutes on battery power.There were no patient health consequences reported.

Manufacturer Narrative

The affected device was examined onsite by technician and the logfile was provided for further investigation at the manufacturer¿s site.Based on the investigation the reported event could be verified and a device shut down due to a completely discharged battery could be confirmed.If the device is neither connected to mains power nor equipped with an external battery, the device switches to the internal battery with audible alarm and the display message "internal battery activated" occurs.During the discharging process the device indicates ascending alarm messages from ¿int.Battery activated¿ via ¿int.Battery low¿ to ¿int.Batt.Almost discharged¿.When the battery is completely discharged, the device 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.Based on the logfile analysis it could be confirmed that the device generated appropriate ascending alarms indicating the decreasing battery capacity; however, the very short time span between these alarms during discharge is a hint of the reduced capacity / worn out state of the internal battery.Replacing the internal battery remedied the issue and the device passed the test according to the manufacturer's specification as 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.

Event Description

It was reported that the device only works for 8 minutes on battery power.There were no patient health consequences reported.

• 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: 11736361
• MDR Text Key: 250038504
• Report Number: 9611500-2021-00183
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)200814(17)230601(93)8417800-42
• Combination Product (y/n): N
• PMA/PMN Number: K0180779
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8417800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1