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

Model Number	8414450
Medical Device Problem Codes	Decrease in Pressure (1490); Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator alarmed and either restarted or shut down automatically during use.The ventilator was immediately replaced by another one.There were no patient health consequences reported.
Additional Manufacturer Narrative
The investigation was started; the results will be provided in a follow-up report.
Additional Manufacturer Narrative
The affected device was examined onsite by dräger service and a faulty internal battery and a faulty power supply were identified as root cause of the reported issue.Replacing the internal batteries and the power supply reportedly remedied the issue.The affected device, savina, sn: (b)(6) was manufactured in march 2018.The savina device is equipped with safety features to detect an aged battery or a battery with a decreasing capacity prior to device use and during device operation.In such a situation, the device generates corresponding alarm messages to which the user can respond and thus prevent an interruption of an ongoing ventilation due to a power loss.The user is requested to regularly perform adequate maintenance to the internal battery according to the instructions for use; the internal batteries are maintenance parts and must be replaced every 2 years according to the instructions for use.Furthermore, the user must check prior to each patient use, if the remaining capacity of the internal batteries allow the device to switch over to the internal battery in case mains power is not available.In the current event, the device alarmed reportedly as specified.During a reboot or unexpected shutdown of the device, the pneumatic system opens, which reduces airway pressure to ambient pressure and spontaneous breathing is possible for the patient.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 or Problem Description
It was reported that the ventilator alarmed and either restarted or shut down automatically during use.The ventilator was immediately replaced by another one.There were no patient health consequences reported.

• Brand Name: SAVINA
• Common Device Name: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 19592530
• Report Number: 9611500-2024-00264
• Device Sequence Number: 15576625
• Product Code: CBK
• UDI-Device Identifier: 04048675016403
• UDI-Public: (01)04048675016403(11)180313(17)210101(93)8414450-47
• Combination Product (Y/N): N
• PMA/510(K) Number: K003068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8414450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown