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

Catalog Number 8606500

Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported during a power switch the machine rebooted, and the screen turned blue and unresponsive.The battery life of the device was fluctuating after reboot.No patient injury.

Manufacturer Narrative

For investigation the log file was available, as well as the replaced power supply.The power supply showed no malfunction.In the log file the reported power failure and restart can be confirmed.The battery charge status showed 0% and it was registered that the battery need to be replaced.The user was informed about the battery status during self test.Due to the following mains power failure the device shut down immediately.As the mains power returned the device alarmed with ventilator fail.Thus, it can be concluded that the battery pack was defective due to deep discharge.It is possible to use the device with mains power only, but in case of mains power loss the device shuts down immediately.Manual ventilation remains possible.The batteries are subject to an aging process and need to be replaced periodically during maintenance every 3 years.With a completely charged battery ventilation can be continued with the current settings for at least 30 minutes (up to 90 minutes, depending on the ventilation parameters).

• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 16866852
• MDR Text Key: 314533140
• Report Number: 9611500-2023-00163
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)151021(93)8606500-59
• 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
• Report Date: 03/07/2023,05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2023
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• 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
• Treatment: NA.