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

Catalog Number	8607300
Medical Device Problem Codes	Use of Device Problem (1670); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was performed based on the provided device log file and analysis on site.According to the log records it was found that on the reported date of event march 28th, 2024, two ventilator failures occurred.The first one was caused by depleted batteries.The device posted a power failure at 8:14 and continued operation on battery supply.Additional alarms at 9:34 and 9:38 informed the user that only 20% respectively 10% of the battery capacity are left.According to the instructions for use a completely charged battery can ensure supply for at least 45 minutes.As the device was running on battery for over an hour this criterion was fulfilled.As a battery failure can be excluded it can be concluded that a missing user action caused the stop of automatic ventilation due to depleted batteries.The device has reacted to the situation as specified and has posted alarms to inform the user about the situation.The second ventilator failure was caused by a membrane vacuum which exceeded the maximum value for auto-ventilation.Possible root causes are a squeezed tubing, an issue with the vacuum pump or a blocked pump filter.The device was inspected by the service technician and the vacuum problem could not be duplicated.The vacuum pump pressure was found to be within specification.The ipm-l was completed without any abnormalities.Based on these findings it can be assumed that the failure was only temporary, e.G.Caused by a squeezed hose.For both situations described above the ventilator stopped the automatic ventilation and an audible and a visible alarm message ¿ventilator failure¿ was displayed.In this case automatic ventilation is no longer possible.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.The number of similar cases, related to the same root cause/ symptom, 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 there was a ventilator failure during use.No injury reported.

• Brand Name: FABIUS MRI
• 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: 19189971
• Report Number: 9611500-2024-00182
• Device Sequence Number: 20950757
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)180316(17)180811(93)8607300-45
• Combination Product (Y/N): N
• PMA/510(K) Number: K072884
• 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): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2018
• 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