MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA APOLLO; ANESTHESIA UNITS

Catalog Number 8606500

Device Problems Premature Discharge of Battery (1057); Energy Output Problem (1431); Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)

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

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that a power failure occured and the device shut down during use.No patient injury was reported.

Manufacturer Narrative

The dispatched dräger service engineer could not duplicate the error condition during an on-site check.However, by means of an initial log file review the reported shutdown during use could be confirmed.It was decided to replace the power supply unit and the internal battery; it was verified by testing that the device was fully functional again afterwards.The replaced parts have been returned to the manufacturer for evaluation.The power supply was free of faults and thus, can be excluded as a contributing factor.The internal battery was found used-up with a residual capacity of 18% only which explains that a premature shut-down is likely to occur when the device runs on batteries.The log file provides evidence that a supply voltage error for the ventilator has occurred whereupon the device responded with a shut-down of automatic ventilation and the generation of a corresponding alarm.About 2.5 minutes later the device alarmed for an underrun of 10% residual battery capacity.The device was then power-cycled by the user five minutes later; the automatically starting self-test was aborted and the device was further used for six hours until it was placed into standby.The likely interpretation for the user's experience would be the following: the device ran on battery during the course of event and - due to worn status of the latter - the output voltage went below 24v which is the supply voltage for the ventilator motor.The shut-down of ventilation was the system response upon that error condition.The fact that no event of mains power loss was recorded in the log is not necessarily a conflict - the generation of this type of log file entry can be disabled by the user.Obviously, the supply with mains power could be re-established by the user during troubleshooting before restarting the device.This may even have been made unnoticedly and, further operation was possible.Dräger finally concludes that the event does not incorporate a previously unidentified or falsely assessed risk and that it was the consequence of a combination of use errors.The battery is subject to aging and thus, it is recommended to replace it at least every three years as a preventive measure.In individual cases this might be necessary earlier when the frequency of discharging/charging cycles is high or when deep-discharging has occurred.During use of the device, the energy source on which it is currently operated is being displayed continuously on the screen.Furthermore, it is part of the daily power-on self-test routine to verify if the battery is capable to supply the device with energy, deviations will be alarmed by the piezo buzzer integrated in the power supply.

Event Description

It was reported that a power failure occured and the device shut down during use due to a depleted battery.No patient injury was reported; patient support was continued in manual ventilation.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• 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
• MDR Report Key: 15110705
• MDR Text Key: 302199801
• Report Number: 9611500-2022-00172
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2014
• 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