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

Catalog Number 8606000

Device Problem Insufficient Information (3190)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

The electronic log file was available for investigation.As the device has been used since the reported event, the user log entries for the reported date of event have already been overwritten.However, analysis of the error log confirmed the reported event in general.At 14:40:57 on the reported date of event, the device detected a power fail, performed a warm start and switched to safety mode.At 14:41:04 a change of ventilation settings is logged.This change is made by the device in accordance with the specification by switching to man/spont.At 14:42:12, a power cycle and an error-free post (power on self test) are recorded.There wasn't any failure of the device detected during this test.Based on all available information the exact root cause could not be determined, but it is seen likely that the battery was not suffiently charged when mains power failed.Even with a swithed-off device, manual ventilation with up to 12l/min o2 and volatile anesthetic agent remains possible to continue the case.

Event Description

It was reported that on february 26th the unit shutdown during a case when there was a mains power failure at the hospital.No reported patient injury, the staff manually ventilated the patient until mains power was restored.The device had been used since then without further problems reported.

• 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: 19189969
• MDR Text Key: 341119372
• Report Number: 9611500-2024-00181
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)160321(17)160817(93)8606500-61
• 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: 04/26/2024

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: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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