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

Catalog Number 8606500

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 05/27/2022

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 the device shut down during use.The case was continued using manual ventilation.There was no injury reported.

Event Description

It was reported that the device shut down during use.The case was continued using manual ventilation.There was no injury reported.

Manufacturer Narrative

The device was inspected by dräger in follow-up of the event.When powering it on the device did not start-up and alarmed for power failure.The device was switched-off and, the power supply was replaced in abundance of caution.The workstation was powered back on after a phase that allowed the batteries to recharge.Start-up behavior was normal and, the batteries had reached a charging level of 100%.The device passed all tests and was returned to use.The replaced power supply was returned to manufacturer for evaluation.It was installed into the periphery of a lab device and subject to an in-depth test but did not exhibit any malfunction.Evaluation of the log file revealed the following: a mains power loss had occurred at 12:05 am system time and, operation was continued on battery.Approx.2.5 hours later the residual capacity had underrun 10%; the device posted a corresponding alarm as specified.The device remained in use until the battery was fully depleted and, operation was not possible anymore.A power-fail alarm was posted.Manual ventilation with the built-in breathing bag remains possible in this state.From these facts, the following can be concluded: it is specified behavior that the device posts a power-fail alarm when being turned on with fully depleted batteries - this is to indicate that there is no alternative power source available in case of mains power loss.Most probably lack of knowledge about this behavior has led to the perception that the power supply was faulty which indeed had no malfunction.With fully charged batteries the device can be operated for a minimum of 30 minutes with challenging settings; the operation time with typical ventilation parameter is 90 minutes.In the particular case the device was operated for more than 2.5 hours after the power loss with a short period in between where mains power was available again.This may explain the comparatively long overall runtime of 2.5 hours.A reasonable explanation for the short-term return of mains power during the period in question would be an incompletely plugged power cord.This may have led to false perception of the user about the energy source the device was running on.Factually, there is likely no issue with the device which would require repair or correction; it was used in battery operation until the latter was depleted.There's evidence that the device has indicated the mains power loss by a corresponding alarm as intended; the battery depletion alarm was also posted as expected.The residual capacity is being displayed continuously.Hence, it is finally concluded that the reported event was related to a combination of certain use errors.The user however could manage the situation - patient support was continued in manual ventilation until a replacement device was available; no patient consequences have occurred.

• 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: 14731220
• MDR Text Key: 297539589
• Report Number: 9611500-2022-00147
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• 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: 07/01/2022
• 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