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

Model Number	8606500
Medical Device Problem Codes	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	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device was used the second time on the date of event (see (b)(4)).After the first ventilation and before starting the second, a power-on self-test (post) was not succesfully performed.The ventilator could not build up control pressure (code 14.1401).Nevertheless, ventilation was started about one hour later.For the investigation the logfile was analysed.It was possible to comprehend the described problem.It was found that during ventilation the device detected a too low (negative) vacuum pressure in the piston and alarmed according to specification for this failure case.The vacuum pressure is used for actuation of the valves that control the ventilation and for keeping the diaphragm of the ventilator in place during piston movement i.E.To avoid wrinkling.As automatic ventilation could not be maintained the user finished ventilation by using the built-in breathing bag as intended.It was not possible to determine the exact root cause, however, based on experiences, it was assumed that the upper diaphragm of the ventilator was not correctly assembled.The ventilator diaphragm is a detachable component and typically removed for cleaning and disinfection and reinstalled after reprocessing by the user.An incorrect assembly is widely prevented by the mechanical design of the housing, the diaphragm and the breathing system.Nevertheless an incorrect assembly can¿t be ruled out totally.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.
Event or Problem Description
It was reported that the unit displayed an alarm check ventilator assembly during case and started having leakage issues.No injury was reported.During investigation this case was found to be reportable, other than initially assumed.

• 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: 19805102
• Report Number: 9611500-2024-00307
• Device Sequence Number: 8389044
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)171204(93)8606500-64
• Combination Product (Y/N): N
• PMA/510(K) Number: K042607
• 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
• Report Date (Section B): 07/23/2024

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: 07/18/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2017
• 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