MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS TIRO; ANESHESIA UNITS

Catalog Number 8606000

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

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

Event Date 06/18/2021

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 ventilation was "sluggish" and there was a loss of tidal volume.Based on log analysis it was found that also a ventilator failure occurred after the date of event being in context with the reported symptoms.No patient injury reported.

Event Description

It was reported that ventilation was "sluggish" and there was a loss of tidal volume.Based on log analysis it was found that also a ventilator failure occurred after the date of event being in context with the reported symptoms.No patient injury reported.

Manufacturer Narrative

The customer had reported two events with this anesthesia workstation to dräger: the first event with doe (b)(6) 2021, initially described a ventilator failure during a procedure performed on the respective day which was however corrected by the user later-on to an observed significant reduction of applied tidal volumes.The second issue with a doe of (b)(6) 2021, was also initially described as a vent fail but later corrected to significantly reduced tidal volumes as well.Initial log file review revealed that indeed a ventilator failure had occurred on (b)(6) 2021.Since investigation was just started with results pending i.E.No possibility to exclude vent failures for these, both events addressed by the customer were reported to the authorities in abundance of caution (doe (b)(6) 2021 ¿ mdr# 9611500-2021-00286; doe (b)(6) 2021 ¿ mdr# 9611500-2021-00294).For better overview and understanding of the entire story, a comprehensive evaluation statement is put into each follow-up report.For the doe june 11th, no indication for the potential presence of a device malfunction could be found.The log provides evidence that the device was disconnected from mains power for 30 minutes but the transmitted information suggested that this was happening prior to the concerned procedure.When the dräger engineer arrived on-site, the hospital¿s biomed had already replaced the lower piston diaphragm and confirmed that the unit performed according to specification.Dräger was called-in again after the device exhibited further problems on june 18th.Prior to arrival of the dräger service engineer the biomed had replaced the vacuum pump of the device.The dräger service engineer replaced the ventilator motor and both upper and lower piston diaphragms as a precautionary measure.The device was tested and returned to use with no further problems reported to date.The replaced parts were subject to an in-depth evaluation in the manufacturer¿s lab but did not exhibit any non-conformities during the tests.Finally, no clear explanation for the reported events could be found; a causal connection to a problem in the pneumatic circuit of the auxiliary vacuum is however most likely.The auxiliary vacuum pressure is needed to operate the valves that control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement to avoid wrinkling.Upon a significant pressure drop caused by e.G.A leak to ambient, the system will respond with a safety shutdown of automatic ventilation to prevent from potentially hazardous output caused by valve malfunctions and/or damages to the ventilator unit resulting from a dislodged piston diaphragm.Parts of this pneumatic circuit had been replaced by the hospital¿s biomed without prior inspection by the manufacturer ¿ most probably this has rectified the problem already; the other components of this functional subsystem were replaced by dräger but exhibited no deviation.

• Brand Name: FABIUS TIRO
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 12133804
• MDR Text Key: 262885572
• Report Number: 9611500-2021-00294
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042419
• 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: 08/17/2021

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: 8606000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1