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

Catalog Number 8607000

Device Problems Gas Output Problem (1266); Tidal Volume Fluctuations (1634); Failure to Deliver (2338); Gas/Air Leak (2946); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that the volumes were not delivered correctly, i.E.Volumes delivered were not what were set in volume control ventilation.Based on the preliminary review of provided information, it was found that the peep dropped to ambient pressure during the case in question.There was no patient injury reported.

Event Description

Please refer to initial mfr.Report #9611500-2019-00426.

Manufacturer Narrative

The investigation was carried out based on the available information and the submitted logfile.Based on the logfile analysis, no entries related to the reported symptom could be found.However, it is known from other complaints and plausible that the reported symptom was caused by a sticking peep-valve placed inside the cosy.It was further reported, that the biomed has replaced this valve and put the device back into use.Issues with contamination or assembling of the peep-diaphragm could have caused increased friction inside the valve assembly causing the sticking.Since the service report and additional information has not been received, even though requested three times, the exact root cause could not be determined.In general, the device features an integrated pressure and volume monitoring.Depending on the limits adjusted by the user, the device will generate appropriate visible and audible alarms.The replacement of the affected peep-valve in follow-up to the event has reportedly solved the problem, no patient consequences have reportedly occurred.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9449335
• MDR Text Key: 186766340
• Report Number: 9611500-2019-00426
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1