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

Catalog Number 8606000

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

The facility did not involve the local dräger s&s organization into examination and repair of the device.A logfile was not available for the investigation at the manufacturer.A case-specific evaluation was thus not possible.The device was manufactured in september 2011.In general the device is designed to post an alarm if mains power gets lost for any reason and to continue operation on battery supply.The residual battery capacity is being displayed; with a fully charged battery the minimum runtime is 30 minutes.Manual ventilation with the built-in breathing bag remains possible even in switch-off state.It was not possible to determine the exact root cause for the described issue.On site a mainboard was exchanged; no further details were provided.In fact, it is not clear if the device was in use during the event and a transient voltage spike resulting from the power loss in the care unit has led to a damage of the electronics in the anesthesia device resulting in shut-down.Another potential explanation would be that the activation failure of the device and the power outage were two independent events ¿ the device was not used before and should have been put into operation after the power loss which was not possible due to a malfunction that was present before start-up already.Other scenarios would be imaginable as well and, a differentiation is not possible due to lack of information.The device is about 12 years old; a malfunction of a single electronic component after such long time of use can be considered acceptable.Appropriate risk mitigation measures are in place.H3 other text : device not available for investigation, 3rd party service.

Event Description

It was reported that the anesthesia recovery room suddenly experienced a power outage and the anesthesia machine could not be turned on after the power is restored.A black screen appeared.No injury was reported.

• 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: 18356659
• MDR Text Key: 330957705
• Report Number: 9611500-2023-00474
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2023

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: 09/19/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2011
• 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