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

Model Number	8607300
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a ventilator failure occurred during use.There was no patient injury reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
It was further mentioned in the information received from the user facility that a biomed had tested the device in follow-up of the event.Operation on internal batteries reportedly worked as intended but when attempting to test the device with mains power connected it reportedly switched off and, it was per report not possible to turn the device on.Based on this additional information it was recommended to replace the device-internal power supply and the so-called control box which is the central control unit.These parts were returned to the manufacturer for evaluation.They have been installed into the periphery of a lab device but did not exhibit any deviations from specification during extensive testing.The log file was evaluated by the manufacturer.It could be determined that the device was powered on on the doe at 13:10 system time; an ac power fail was logged for the same minute.The log further indicates that ac power was restored 3 minutes later but failed again at 13:36 and was restored within the same minute.No traces could be found that indeed a ventilator failure has occurred as reported.The system is designed to continue operation on battery if mains power gets lost.The charging state can be observed by the user continuously and, alarms are generated as soon as the residual capacity underruns 20% and 10%, respectively.Such an event would produce a log file entry but no such entry can be found.Additionally, the tests reportedly performed by the hospital's biomed demonstrate that operation on battery worked as intended.These tests performed by the biomed two days after the event are evident in the log entries as well.Three instances of power fail can be seen with consecutive restoration of ac power each time afterwards; it must be assumed that the ac power was intentionally disconnected to test the device.It can furthermore be derived from the records that the device was switched on for more than ten times on that day whereby the aspect in the user's report about failure to power up during testing can be denied as well.Dräger asked for a more detailed description of the course of event but none was provided.All in all, no indication for the presence of a ventilator failure could be found and thus, no explanation for the user's experience can be given.
Event or Problem Description
It was reported that a ventilator failure occurred during use.There was no patient 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
• MDR Report Key: 13051922
• Report Number: 9611500-2021-00529
• Device Sequence Number: 1751895
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)160812(17)170110(93)8607300-42
• Combination Product (Y/N): N
• PMA/510(K) Number: K072884
• Number of Events Summarized: 1
• Summary Report (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): 06/16/2022

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: 8607300
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2016
• 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