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

Device Problems Gas Output Problem (1266); Failure to Run on Battery (1466); Decrease in Pressure (1490)

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

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility did not involve the local dräger s&s organization in device examination and repair.Dräger was seeking contact to the hospital to obtain further information.It could be revealed that the device is back in use after the hospital's biomed had replaced the outdated internal battery.Dräger finally concludes the following: it is not plausible that the ventilation fully stops due to an overaged battery if the device is connected to mains supply at the same time.The most likely scenario is that the device performed a single restart due to a failed internal battery check.The device software performs a battery test procedure in the background in regular intervals to calculate the battery status and the runtime forecast.If a particular test instance fails due to an outdated or depleted battery this may trigger a reboot of the entire device.During a reboot sequence the airway pressure will be released to ambient and the device posts an alarm to alert the user about the reboot.After a typical period of 12 seconds the reboot will be completed and the device resumes ventilation with previous settings.The internal battery has to be replaced after two years of use.The particular device was in operation for more than 3 years now and the transmitted information confirms that the battery was overaged i.E.The device was still equipped with the initial battery installed at the time of manufacture.Lack of maintenance has contributed to the event.

Event Description

It was reported that the device alarmed for battery failure during use and stopped ventilation.The users have reportedly replaced the device immediately; no patient consequences have occurred.

• 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: 11632867
• MDR Text Key: 249280181
• Report Number: 9611500-2021-00151
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K003068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2017
• 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