MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GSP; 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 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device was checked on-site by an engineer of the local dräger s&s organization.It was found during log file analysis that the shut-down of automatic ventilation was a system response to a drop in the auxiliary vacuum pressure.The auxiliary vacuum pressure is required to keep the ventilator diaphragm in place during piston movement and to actuate the valves which control the ventilation cycles.If the vacuum pump cannot build-up the necessary pressure level or fails completely, automatic ventilation is not possible.If this condition is present already during pre-use check the device will respond with a failed self-test result.In case of occurrence during use the device will force a shut-down of automatic ventilation and post a corresponding alarm.Manual ventilation with the built-in breathing bag will still be possible then.The service engineer found no issue with the pump itself; the pcb which generates the supply voltage for the vacuum pump was replaced as a precautionary measure.The device passed all consecutive tests and was returned to use.The replaced pcb was tested in the manufacturer's lab but did not exhibit any deviation from specification.Thus, evaluation remains inconclusive - the issue may have been related to a leak in the particular pneumatic path.For example, if one of the small tubes that is required to actuate the apl bypass or the peep valve comes off this will also lead to a significant drop in vacuum pressure.Finally, it can be concluded that the device responded as designed upon an error condition unknown origin which may lead to potentially hazardous output or to severe damages to the ventilation unit; automatic ventilation was shut down and, the user was alerted by means of a corresponding alarm.

Event Description

It was reported that there had a ventilor failure occurred in two differerent surgical procedures.As per report, no patient consequences have occurred in any of the cases.Remark: an individual report is filed for each instance of ventilator failure - please see also.

• Brand Name: FABIUS GSP
• 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: 15876490
• MDR Text Key: 307481497
• Report Number: 9611500-2022-00325
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)201119(17)210316(93)
• 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
• Report Date: 11/02/2022,11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• 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
• Date Report to Manufacturer: 11/02/2022
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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