MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNIT

Catalog Number 8603800

Device Problems Failure to Run on Battery (1466); Failure to Deliver (2338); Complete Loss of Power (4015)

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

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

The dispatched dräger service engineer tested the workstation in follow-up of the event and could not identify a deviation from specification except a depleted internal battery.The course of event could be reconstructed as follows: indeed the device posted a ventilator failure alarm during the concerned procedure because the device was running on internal battery and, the voltage had underrun the minimum threshold that is required to drive the ventilator motor.It was later determined that the device was not properly connected to mains supply.After reconnecting the device to mains power, the unit was fully functional again, charging of the internal battery was possible as well.When powered-on, the device clearly signalizes if it runs on mains supply or on internal battery.The residual capacity is being displayed continuously and, the device will post alarms if the latter underruns 20% and 10%, respectively.At full depletion of the battery, a power loss alarm powered by an independent power source will be generated.The log file indicates that the power-on self-test performed in the morning of the doe was passed w/o deviations, the internal battery was charged to 100%.Further, there's evidence that the depletion alarms were posted as expected.It is not known why the users could not manage to manually ventilate the patient - the device design allows manual ventilation with the built-in breathing bag for which the gas flow has to be set manually; the procedure to establish the emergency gas dosage is explained in the ifu.Finally, it can be concluded that there is no issue with the device which would require repair or correction; the event was caused by a chain of use errors with a likely relation to lack of training.Appropriate risk mitigation measures are in place.

Event Description

It was reported that the device suddenly posted a ventilator failure during use.As per report, the users weren't able to perform manual ventilation with the built-in breathing bag and replaced the device in a controlled maneuver; no consequences to the patient's health were resulting from the event.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNIT
• 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: 19095399
• MDR Text Key: 340804944
• Report Number: 9611500-2024-00162
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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