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

Catalog Number 8604700

Device Problem Ventilation Problem in Device Environment (3027)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation was performed based on the provided information as no log file was available.Reportedly the error log contained the following entries: patient airway pressure very (b)(6) (less than -10mbar), motor slow, motor stalled.The problem of a too slow and stalled motor could be confirmed during testing on-site so that finally it could be determined by the service technician that the ventilator motor was root cause for the reported ventilator failure.A negative patient airway pressure can be an indication for a low pressure within the ventilator being a result of a too low fresh gas flow in combination with a sticking auxiliary air valve.This could subsequently also lead to a slow/stalled motor.But as this symptom normally is accompanied by other error log entries which were not reported this can be excluded.Therefore it can be assumed that the (b)(6) patient airway pressure was most likely related to the surgical case.As in case of a slow or stalled motor the fabius cannot deliver the required tidal volume automatic ventilation is stopped accompanied by a corresponding alarm.Manual ventilation is still possible.Replacement of the ventilator assembly with motor and light barrier cable has solved the reported symptom.The unit was tested afterwards and was handed over to the user ready for use.

Event Description

It was reported that during a case the ventilator failed.The patient was manually ventilated and the case was completed.No patient injury reported.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 8288083
• MDR Text Key: 134461773
• Report Number: 9611500-2019-00030
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2008
• 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