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

Catalog Number 8607000

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that during a case the machine alarmed "vent failure" and that the patient had to be bagged for the duration of the case.No patient injury reported.

Event Description

It was reported that during a case the machine alarmed "vent failure" and that the patient had to be bagged for the duration of the case.No patient injury reported.

Manufacturer Narrative

The initial log file evaluation revealed that the device forced a shut-down of automatic ventilation during the procedure in question after having detected a deviation of the ventilator motor's rotation speed.Based on this expertise the motor including position detection system had been replaced; the device passed all the consecutive tests and is back in use.The replaced parts were subject to an in-depth evaluation in the manufacturer's lab.Although having accumulated almost 50.000 operational hours, the motor was in good condition and did not exhibit any deviation from specification.In the optical encoder unit, a piece of foreign material was found.Most likely it was a surplus of glue material that had been loosened over time.It would be imaginable that this peace of material has compromised the optical motor position detection.The motor drives the piston up and down in left/right rotation via a spindle; the number of rotations is proportional to the piston hub and thus, to the volume applied by the ventilator.To protect the patient from potentially hazardous output, motor position, rotation speed and acceleration must be monitored continuously.If the measured values have a significant deviation from the ones calculated by the software, the system is designed to shut-down automatic ventilation for safety reasons.The user will be alerted by means of a corresponding alarm; manual ventilation including gas dosage remains available then.There is no comparable case known and, dräger finally concludes that the underlying scenario does not incorporate a previously unidentified or falsely assessed risk.

• Brand Name: FABIUS GSP
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11138853
• MDR Text Key: 225734650
• Report Number: 9611500-2021-00009
• 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: 02/11/2021

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: 8607000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.