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

Catalog Number 8607300

Device Problems Use of Incorrect Control/Treatment Settings (1126); Unexpected Therapeutic Results (1631); Use of Device Problem (1670)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

The investigation has been started; results will be provided within the follow-up report.H3 other text : on-going.

Event Description

It was reported that the patient desaturated and the patient turned blue during ventilation.During on-site checking in follow-up to the event, no problems were found based on checked error log and device.However, a use-error contributing to the patient's outcome could not be excluded.Since the date of event was not reported, (b)(6) 2023 was set as date of event when the case was opened from service intervention.

Manufacturer Narrative

According to the description of the event the patient has turned blue and got desaturated in mid of ventilation.During on-site checking in follow-up to the event, no problems were found.A log analysis at manufacturer site has also not revealed any conspicuous entry related to an oxygen deficit.Nevertheless, based on the reported patient outcome it can be assumed that the patient most likely was ventilated with a hypoxic gas mixture.The involved fabius workstation is equipped with an auxiliary common gas outlet (acgo) which will typically be used during the induction phase for supplying fresh gas to an external non-rebreathing manual ventilation system.The routing of the fresh gas has to be proceeded with the dedicated mechanical switch which has to be flipped to either acgo or to ventilator position.If the switch is in acgo position while the patient is connected to the ventilator, the oxygen uptake of the patient will not be compensated by new fresh gas and the volume of gas that is cycling in the re-breathing pneumatic circle of the ventilator gets more and more hypoxic.Based on the available facts ¿ this is the most likely explanation for the reported event even if the question about the position of the switch during the procedure in question could not be answered.The correct use of the acgo is described in detail in the ifu.Patient gas monitoring is mandatory for anesthetic procedures; especially measurement of fio2 with patient-specific alarm levels is of high clinical significance.With an adequately adjusted threshold for the "fio2 low" alarm there is enough room to react upon the signs of inadequate ventilation.Dräger has published a field safety notice regarding this topic of accidential wrong use of the acgo switch and verified that the user facility had received it.Therefore, the case is rated as use error.

Event Description

It was reported that the patient desaturated and the patient turned blue during ventilation.During on-site checking in follow-up to the event, no problems were found based on checked error log and device.However, a use-error contributing to the patient's outcome could not be excluded.Since the date of event was not reported, (b)(6) 2023 was set as date of event when the case was opened from service intervention.

• Brand Name: FABIUS MRI
• 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: 17884011
• MDR Text Key: 325063367
• Report Number: 9611500-2023-00351
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K072884
• 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: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2011
• 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