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

Catalog Number 8606000

Device Problems Failure to Deliver (2338); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported the device would not ventilate during use.No injury reported.

Manufacturer Narrative

Based on the log file analysis the case could be reconstructed as follows: during downward movement of the piston the device detected that a negative airway pressure has been built-up to a certain level which is an indication for a fresh gas deficit.In such situation the device is designed to open an auxiliary air intake valve to compensate the fresh gas deficit by taking-in ambient air.It can be assumed that for the case in question this did not work or the air intake was not proceeded fast enough, resulting in a further increase of the negative airway pressure.The device consequently stopped piston movement temporarily and posted a "vent fail" alarm.If the negative pressure again falls below the threshold ventilation will resume automatically.As the paw sensor or auxiliary air valve potentially can contribute to the described symptom these components were tested on-site by a technician without finding any deviations from specification.During a simulated ventilation the issue could also not be duplicated.Additionally, the device was checked by the biomed over night whereby no alarms or issues were identified.Finally, the root cause for the reported symptom could not be determined.The unit was released for use without further probelem reported since then.

Event Description

It was reported the device would not ventilate during use.No injury 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
• MDR Report Key: 15483020
• MDR Text Key: 300594018
• Report Number: 9611500-2022-00244
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2005
• 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