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

Catalog Number 8606000

Device Problem Insufficient Information (3190)

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

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

The user facility did not involve the local draeger s&s organization into examination and repair of the device.Dräger contacted the hospital asking for further information.It was responded that the device is back in use after a repair ingress made by the biomedical department - a hose has reportedly been replaced but the contact person did not provide further details which hose the speech was about.This lack of information does not allow a case-specific evaluation and, this report is being filed in abundance of caution.Based on experience, the most likely explanation would be the following: the expiratory valve is actuated pneumatically via a small hose that is routed from the back of the device to the compact breathing system - the functional unit which contains all the valves that control the ventilation cycles.It would be imaginable that the tube may have become detached unintendedly during interaction with the device or when moving the unit.The system effect would be a drop in vacuum pressure which will end up in a safety shut-down of automatic ventilation to prevent from damages to the ventilator unit - this is the specified device response upon the tube detachment and, such an event must be attributed to use error then.Other scenarios would be imaginable as well; a differentiation is not possible since even not the aspect of ventilator failure can be confirmed or denied on the base of the available facts.If automatic ventilation fails or is shut-down for safety reasons, manual ventilation with the built-in breathing bag as well as gas dosage is still possible; pressure and flow monitoring remains functional as well.

Event Description

It was reported that the ventilator failed during use.As per report, patient support was bridged in manual ventilation until a replacement device was made available.Remark: the user facility report mentions the following: "the malfunction of important life-support device during the operation seriously delayed the patient's surgical progress and had an extremely adverse impact on the patient." it could however been clarified with the hospital in follow-up of the event that indeed there was no delay in surgery and that the event did not lead to consequences for the patient.It is concluded that the user's statement refers to potential consequences the ventilator failure might have.The case is thus classified as a product problem and not as an adverse event.

• Brand Name: FABIUS TIRO
• 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: 18578344
• MDR Text Key: 334756667
• Report Number: 9611500-2024-00024
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)180504(17)181003(93)8606000-85
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2024

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: 01/08/2024
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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
• Treatment: NA.