MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION NC; VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC

Model Number	8417400
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
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 hospital experienced a sudden power outage, activating the ventilator's battery.The ventilator alarmed almost immediately for low battery and shut down shortly after.The nurse promptly assisted the patient with an ambu bag.Power was restored 28 minutes later, and the ventilator operated normally afterwards.There were no health consequences for the patient reported.
Event or Problem Description
It was reported that the hospital experienced a sudden power outage, activating the ventilator's battery.The ventilator alarmed almost immediately for low battery and shut down shortly after.The nurse promptly assisted the patient with an ambu bag.Power was restored 28 minutes later, and the ventilator operated normally afterwards.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The investigation was based on the initial information.Further information was requested but not provided.Based on the available information a case specific evaluation is not possible.A root cause for the shortened runtime of the device on battery power cannot be determined.The device is equipped with an internal battery to ensure continuous operation in case of mains power loss or during transport.The internal battery is a wear part which has to be regularly check for its capacity and replaced in regular intervals of 2 years.Corresponding instruction for maintenance can be found in the instruction for use.The capacity of the internal battery changes with increasing age and utilization, such as discharge / recharge cycles or temperature.In case of mains power loss, the device will be supplied from the battery in order to continue operation.Switch-over to battery operation is indicated with a corresponding alarm message.Depending on battery capacity and battery voltage further ascending alarm messages will be posted with progressive battery operating time.In case of a complete power loss (ac mains and battery) the safety valve will open to ambient allowing the patient for spontaneous breathing.In addition, the acoustical auxiliary alarm will be activated in order to alert the user.This alarm is energized independently from the power supply and will last for at least 2 minutes.However, it may be considered necessary to continue the ventilation with another independent device.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: INFINITY ACS WORKSTATION NC
• Common Device Name: VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC
• 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: 20449707
• Report Number: 9611500-2024-00437
• Device Sequence Number: 7110679
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)181017(93)8417400-17
• Combination Product (Y/N): N
• PMA/510(K) Number: K093632
• 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): 11/11/2024

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: 8417400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2018
• 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
• Patient Sex: Unknown