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

Catalog Number 8606500

Device Problems Device Difficult to Program or Calibrate (1496); Failure to Deliver (2338); Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results will be provided in a separate follow-up report.H3 other text : on-going.

Event Description

It was reported that the device stopped ventilating during a case and the screen froze.The case was continued with manual venmtilation.There was no injury reported.

Event Description

It was reported that the device stopped ventilating during a case and the screen froze.The case was continued with manual ventilation.There was no injury reported.

Manufacturer Narrative

The investigation was performed based on the available information.There was no log available.No hardware was replaced.The exact root cause could not be determined without doubt.Based on the statement that the device has been working without any failure since removement of the buffer battery on pba mobi it was concluded that invalid data in the ram memory of the controller system, most probably caused by an emv event, led to this failure.If the display will lock up during use integrated monitoring and selection of parameters / modes would not be possible any more.During automatic ventilation an automatic shutdown of the ventilation mode and switch to the man / spont mode will be done.An alarm will be given via the secondary piezo signal generator of the power supply.It was reported that the device alarmed in this particular case.H3 other text : device not available for investigation.

• 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: 19058403
• MDR Text Key: 339563156
• Report Number: 9611500-2024-00149
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)200723(17)250306(93)8606500-67
• 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
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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: 8606500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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