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

Catalog Number 8606000

Device Problems Device Reprocessing Problem (1091); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation was just started.The result will be provided in a follow up report.

Event Description

It was reported that on (b)(6) 2021, fio2 dropped during ventilation and ventilation was no longer possible.The user tried manual ventilation, but the bag remained deflated.No injury reported.

Manufacturer Narrative

For the investigation the provided information were analyzed.The service engineer on site found that a deformed vaporizer caused a leakage and consequently resulted in a fresh gas deficit.This could be reproduced during logfile analysis, as several times the mandatory leakage test was not passed.Further, it was found for the case in question, that the device detected during downward movement of the piston a negative pressure, which has been built-up to a certain level.This is an indication for a fresh gas deficit.In such situation the device is designed to open an auxiliary air intake valve on top of the ventilator to compensate the fresh gas deficit by taking-in ambient air.This did not work or the air intake was not proceeded fast enough, resulting in a further increase of the negative pressure.The device will then stop piston movement temporarily and post a vent fail alarm.If the negative pressure goes back below the threshold ventilation will resume automatically.Possibly the auxiliary air intake valve was sticking and caused a delay in opening.Based on experience this can be caused by insufficient reprocessing.The instructions for use contains instructions for reprocessing the respective valve.The fse on site has fixed the deformed vaporizer; the workstation passed all consecutive tests and was returned to use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that on (b)(6) 2021, fio2 dropped during ventilation and ventilation was no longer possible.The user tried manual ventilation, but the bag remained deflated.No injury reported.

Event Description

It was reported that on (b)(6) 2021, fio2 dropped during ventilation and ventilation was no longer possible.The user tried manual ventilation, but the bag remained deflated.No injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.Not returned to manufacturer.

• 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: 12999511
• MDR Text Key: 283827512
• Report Number: 9611500-2021-00501
• 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,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2006
• 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