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 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

The user facility did not involve the local dräger s&s organization into evaluation or repair of the device.The device was manufactured in june 2014 but the status of preventive maintenance and repairs is unknown.The user/hospital suspected that a jammed piston of the ventilator assembly caused the problem but on request to obtain further information no additional details about the event and follow-up has been provided.The lack of information does not allow a case-specific evaluation and no reliable conclusion in regard to the potential root cause.In fact, it can even not be confirmed that indeed a ventilator failure has occurred.The manufacturer finally concludes - given that a malfunction of the device has occurred - the device is designed to post a corresponding alarm if automatic ventilation fails.There's a breathing bag integrated to ensure that patient support can be done by means of manual ventilation; a ventilator shut-down has no effect on the gas dosage and the monitoring functions.An assessment which scenario may apply for this particular event is not possible due to missing relevant information.H3 other text : on-going.

Event Description

It was reported that ventilator unit stopped during use on a patient.The device was replaced by a stand by equipment.No injury or serious impairment in patient´s state of health 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: 18128917
• MDR Text Key: 328658877
• Report Number: 9611500-2023-00407
• 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
• Type of Report: Initial
• Report Date: 11/14/2023

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
• Initial Date Manufacturer Received: 11/26/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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