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

Catalog Number 8607400

Device Problems Device Reprocessing Problem (1091); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

The electronic log file was available for investigation.Several log entries indicate that there was a negative pressure detected various times.Based on these log entries it was concluded that the auxiliary air valve was (temporarily) stuck open, leading to restricted automatic ventilation.Depending on the actual situation the system will post corresponding alarms, such as insp o2 low; minute volume low; insp pres not reach; apnea pressure.Software performs a valve test as part of the leak test.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that there was failure of the ventilator during use.There was no injury reported.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9870869
• MDR Text Key: 184630164
• Report Number: 9611500-2020-00089
• 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: 03/24/2020

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: 8607400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2006
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1