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

Model Number 8607000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)

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

Event Date 07/12/2022

Event Type  malfunction  

Event Description

It was reported that the unit alarmed for a ventilator failure during a surgical procedure.Patient support was bridged in manual ventilation until a replacement device was available.There was no patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

The device is serviced by the biomedical engineering team of the hospital.Based on their diagnosis the ventilator motor assembly has been replaced.The workstation passed all consecutive tests after the repair and could be returned to use.The replaced ventilator motor assembly has been returned to the manufacturer for evaluation.Scratches on the motor spindle were detected upon visual inspection but it was impossible to derive if these were signs of wearing or a result of the disassembly.All technical parameter such as start-up voltage, idle current etc.Were within specification, also the incrementer of the position detection system was fully functional.Hence, it can be concluded that the motor has no malfunction and was not the causer for the reported event.The biomed did not provide a log file covering the period in question and thus, the investigation remains inconclusive.Based on experience, a shut-down of automatic ventilation is rather forced by the supervisor function of the system as a protection against potentially hazardous output than being the consequence of malfunctions of the ventilator unit.It is also conceivable that a repair ingress may have removed the source of the deviation unnoticedly.For example: the ventilator unit facilitates an auxiliary vacuum pressure circuit that is used to actuate the valves which control the ventilation cycles and to avoid wrinkling of the piston diaphragm during piston movement.If the vacuum pressure drops below a certain threshold due to leakage the workstation shuts down automatic ventilation.A puncture in the diaphragm may have caused the vacuum pressure drop; an exchange of the diaphragm during motor replacement is likely and eliminates the source of deviation.Other scenarios would be imaginable as well; a differentiation is however not possible due to lack of information.Finally, it can be concluded that the device responded as designed upon a deviation of unknown origin - automatic ventilation was shut down and, the user was alerted to this condition by means of a corresponding alarm.Manual ventilation with the built-in breathing bag remains possible then.

Event Description

It was reported that the unit alarmed for a ventilator failure during a surgical procedure.Patient support was bridged in manual ventilation until a replacement device was available.There was 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 ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 15318679
• MDR Text Key: 303746997
• Report Number: 9611500-2022-00222
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)210201(17)210615(93)8607000-76
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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 Model Number: 8607000
• Device Catalogue Number: 8607000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2021
• 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