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

Catalog Number 8417800

Device Problems Premature Discharge of Battery (1057); Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Complete Loss of Power (4015)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/14/2021

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 "after moving the device in the hospital by battery operation (2 to 3 minutes), the reported device was connected to the outlet and the power lamp was lit, but the battery reduction alarm sounded.The alarm (on the log) was improved once during the connection to the outlet, but the battery reduction alarm rang again.The power was turned off after the alarm sounded in the order of "internal battery less than 30%" and "internal battery less that 10%"." the user switched to manual ventilation and replaced the device with the same model.There was no serious injury reported.

Manufacturer Narrative

The logfile of the affected device was provided and analyzed.Based on the log file analysis the reported event could be verified and a depleted / worn out battery was identified to be the root cause of the event.The device shut off after the internal battery was fully depleted.After connecting the device to an ac power source, the ventilation was resumed and continued.If the savina 300 is not connected to mains power or is not equipped with an external battery, the unit switches to the internal battery with audible alarm and the display message "internal battery activated" is posted by the device.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 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 current event, the device generated the appropriate ascending alarms indicating the decreasing battery capacity; however, the very short time span between the alarms (30 %/10 %) during discharge is a hint of the reduced capacity / worn out state of the internal battery.The internal battery must be replaced.The savina 300 has batteries with lead-gel technology.Batteries of this type perform particularly well when used as a backup battery.If these batteries are used in irregular alternating mode, e.G.In intra-clinical transport (as it was also reported here), the service life is shorter due to technology.A more frequent replacement of the internal battery or the additional use of the external battery option is recommended in this case.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 "after moving the device in the hospital by battery operation (2 to 3 minutes), the reported device was connected to the outlet and the power lamp was lit, but the battery reduction alarm sounded.The alarm (on the log) was improved once during the connection to the outlet, but the battery reduction alarm rang again.The power was turned off after the alarm sounded in the order of "internal battery less than 30%" and "internal battery less that 10%"." the user switched to manual ventilation and replaced the device with the same model.There was no serious injury 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: 11300940
• MDR Text Key: 232399764
• Report Number: 9611500-2021-00050
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)160419(17)190201(93)8417800-24
• 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: 03/22/2021

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 Catalogue Number: 8417800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1