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

Catalog Number 8606500

Device Problems Failure to Deliver (2338); Device Handling Problem (3265)

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

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported that during a case the unit developed a leak and unit went to a ventilator failure.The unit was swapped out.No patient injury reported.

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.H3 other text : on-going.

Event Description

It was reported that during a case the unit developed a leak and unit went to a ventilator failure.The unit was swapped out.No patient injury reported.

Manufacturer Narrative

The device log was requested but was not provided for investigation.Therefore, a detailed reconstruction of the case in question was not possible.A service technician inspected the device on-stie.Thereby, a broken clic canister was identified.During automatic ventilation this leads, depending on the fresh gas flow, to a contamination of fresh gas with room air.Depending on the grade of dilution, the concentration of the individual gases (e.G.O2, n2o or agent) might be significantly reduced.The integrated gas measurement allows a permanent overview of inspiratory and exspiratory gas concentrations to the user.Depending on the set alarm limits, the device issues appropriate alarms (e.G.Insp o2 low, mac low).Due to the fresh gas decoupling valve automatic ventilation is not affected by this leakage.Depending on size of the leakage manual ventilation can be restricted.During power-on self-test (post) and standy leak test as well, internal and external leakages are detected and depending on size a conditional (yellow) or non-functional (red) state is the consequence.For the case in question reportedly the self test was passed before start of the procedure.So it can be assumed that the leakage occurred during use probably caused by mechanical damage.The report of a ventilator failure could not be comprehendend due to lack of a log file.But a ventilator failure can be excluded as a result of a leak in the clic canister.During on-site inspection besides the broken clic canister no other failures were identified that could be related to a vent fail.After replacement of the clic adapter an clic canister the unit was tested and confirmed to be operating per manufacturer's specification.Based on the available information and the investigation results the case was assessed as not reportable in retrospect.

• 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: 18009405
• MDR Text Key: 326562187
• Report Number: 9611500-2023-00383
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2009
• 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