MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS TIRO; ANESTHESIA UNIT

Catalog Number 8606000

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

The user facility did not involve the local dräger s&s organization into any follow-up measures and did not provide further information upon request.The device is not under a dräger service contract, status of preventive maintenance is thus unknown.Even the age of the device cannot be determined since no s/n information was transmitted.A case-specific evaluation is thus not possible, especially in reflection of the aspect that no clear description of the restrictions was provided.This report is filed in abundance of caution since it cannot be fully excluded that ventilation had stopped.Under consideration that it was indeed the case, a stop of ventilation is not necessarily related to a device malfunction.A repositioning of the patient or a coughing in the moment when the ventilator piston applies a breathing hub may lead to a transient airway pressure rise and, the device is designed to abort the ventilation stroke and to alert the user to this condition.The reported aspect that device function was restored autonomously after a short time would also substantiate the assessment that rather physiological or procedural aspects than a device malfunction have caused the reported observation.Finally, other explanations may apply as well and, a differentiation is not possible due to lack of information.It is recommended to the user facility to have the device checked by trained service personnel.When automatic ventilation fails, the device design allows manual ventilation via the built-in breathing bag.

Event Description

It was reported that "the anesthesia machine suddenly failed to work normally" during a surgical procedure.The users reportedly decided to switch to manual ventilation.As per report, the anesthesia workstation restored function after one minute by its own.No patient consequences resulted from the event, it was explicitly mentioned that all vital parameter remained stable during the course of event.

• Brand Name: FABIUS TIRO
• Type of Device: ANESTHESIA UNIT
• 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: 18976905
• MDR Text Key: 338761995
• Report Number: 9611500-2024-00129
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 8606000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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