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

Model Number	8414000
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	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the device frequently restarted automatically during patient use.There were no patient health consequences reported.
Additional Manufacturer Narrative
The affected savina device was examined onsite by dräger service and a faulty internal battery was identified as root cause of the reported issue.Replacing the internal batteries remedied the issue, and the device was returned to service.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 internal battery is a wearing part whose performance and capacity decreases over time.The battery lifetime depends on a number of factors such as, number of battery cycles, battery use profile or improper use, e.G., a deep discharge.According to the instructions for use, the user is requested to regularly perform adequate maintenance to the internal battery.The capacity of the internal battery should be checked every 12 months.If the savina device is used for patient transport a more frequent check is recommended.The internal battery must be replaced every 2 years according to the instructions for use.It is, furthermore, described that the user must check prior to each patient use if the remaining capacity of the internal battery allows the device to switch over to the internal battery in case mains power is not available.During this check, a completely worn out or faulty battery will be detected.In the current case, it is not known if this test has been performed by the user.Based on the investigation, it can be concluded that the affected internal battery had reached its regular end of lifetime.A worn out or deeply discharged internal battery can cause device restarts when the device is operated with ac supply as the savina device periodically checks operation on internal battery for approximately 500 ms.During such a restart the pneumatic system opens, which reduces airway pressure to ambient pressure and spontaneous breathing is possible for the patient.After the restart, ventilation continues immediately with previous settings and no further user action is necessary to resume ventilation.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 device frequently restarted automatically during patient use.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: 19881732
• Report Number: 9611500-2024-00318
• Device Sequence Number: 7088787
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881(11)230202(93)8414000-39
• 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): 09/16/2024

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: 8414000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/13/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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