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 Consequences Or Impact To Patient (2199)

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer investigation was performed based on the provided information including the log file.The logged entries confirm the reported event.If the savina 300 is not connected to mains power or an external battery, the unit switches to the internal battery with audible alarm and displays the message "internal battery activated".This alarm can be acknowledged, so that only one note with the same message remains.Upon further decrease in capacity (<30%), the device alerts the user by generating the alarm "internal battery low".Before the end of the operating time (<10% remaining capacity) the device alarms with the high priority alarm "internal battery discharged".When fully discharged, the ventilation stops and the device switches off with a power failure alarm with high priority, which remains active for at least 2 minutes.Due to the unusual short timeframe between battery related alarm generation (less than one minute), it is likely that the internal battery was damaged or worn and could only hold a reduced capacity.The savina 300 is equipped with 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, the service life is shorter due to technology.A more frequent replacement of the internal battery or the additional use of the external battery 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 during use (battery operation), the device alarmed and shut down.No patient consequences have been 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
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10068753
• MDR Text Key: 191574910
• Report Number: 9611500-2020-00166
• 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
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• 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: 04/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1