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

Catalog Number 8606000

Device Problems Circuit Failure (1089); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 06/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not under a service contract and, since no serial number information is available, the age of the device is unknown.Dräger contacted the user facility to obtain further information.The only additional detail that was provided is that the device is back in use after a repair ingress made by the hospital's biomed who re-soldered a contact point at the controller board to remove the error condition.The exact area where the faulty solder point was located was not named and thus, a case-specific evaluation is not possible.It is even not clear if the error condition was related to the manufacturing process or if a previously performed repair ingress has caused the problem.Dräger finally concludes that an unspecific error condition in the electronic control mechanisms of the device has led to shut-down of automatic ventilation.If such condition occurs the device will post a corresponding alarm to alert the user.Manual ventilation with the built-in breathing bag remains possible and, it is unlikely that the error condition has an effect on the set-up of patient monitoring.

Event Description

It was reported that the automatic ventilation suddenly stopped during use of the device.Patient support was continued in manual ventilation; no consequences have reportedly occurred.

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.

Event Description

It was reported that the automatic ventilation suddenly stopped during use of the device.Patient support was continued in manual ventilation; no consequences have reportedly occurred.

• 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: 12165108
• MDR Text Key: 263474700
• Report Number: 9611500-2021-00306
• 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,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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