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

Model Number	8606500
Medical Device Problem Codes	Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation was just started.The result will be forwarded in a follow up report.
Event or Problem Description
It was reported that the apollo had a ventilator failure in the middle of a case.There was no patient harm due to this.
Event or Problem Description
It was reported that the apollo had a ventilator failure in the middle of a case.There was no patient harm due to this.
Additional Manufacturer Narrative
For the investigation the provided logfile and the returned parts were analysed.The described ventilator failure was confirmed by means of the logfile.It was found that on (b)(6) 2024, the ventilator detected a wrong motor position and forced an autonomous shutdown to safety mode according to specification, directly after automatic ventilation was started.In the following the ventilation mode was automatically changed to man/spont while the appropriate alarm was given.About twenty minutes later, the user restarted the device and continued the ventilation without any further problems.On site the rolling diaphragm was replaced on (b)(6) 2024.The visual inspection showed marks on its surface in form of a hole.Possibly the diaphragm was mounted incorrectly and therfore rubbed against the ventilator housing in an irregular way.For proper function of the ventilator a vaccum is generated between piston and diaphragm to avoid the diaphragm getting wrinkled during operation.In case of a leakage (e.G.Caused by a hole) inside one of these two diaphragms, generation of a sufficient vacuum pressure and thus automatic ventilation might be restricted.Manual ventilation and monitoring functions as well are not affected.The vacuum pressure (min.-80 hpa) is controlled by a pressure sensor.If the lower limit couldn¿t be reached, device alarms for reinstall ventilator and an additional prompt (check ventilator) is displayed.Finally, it is not possible to identify the exact root cause, however it is assumed that the motor was temporarily blocked due to an incorrectly fitted rolling diaphragm.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.

• Brand Name: APOLLO
• Common Device Name: 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: 20244264
• Report Number: 9611500-2024-00392
• Device Sequence Number: 12571473
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)200317(93)8606500-67
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown