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

Catalog Number 8607300

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

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

Event Date 06/30/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that automatic ventilation has stopped during anesthesia.Visual and audible alarms were given.A ventilator failure was displayed.The ventilation could be continued manually.No injury reported.

Manufacturer Narrative

The analysis was performed based on the submitted information including the electronic log file of the device.The reported failure of the ventilator could be confirmed by means of the information stored in the log.The log entries indicate that the vacuum pressure that is required to keep the ventilator diaphragm in place was too low.The fabius reacted as specified for this situation, stopped the automatic ventilation and posted a corresponding alarm.In this case fresh gas delivery (incl.Agent) remains available and the patient can be ventilated using the manual breathing bag.The device was checked on-site by a draeger service technician.It was determined that a cable break in the wiring harness of the pcb control was root cause of the reported event.Due to the cable break the vacuum pump no longer received any voltage and was not able to build up an adequate vacuum anymore.The failure was removed by replacement of the wiring harness.The device was successfully tested after the replacement and was returned to clinical use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that automatic ventilation has stopped during anesthesia.Visual and audible alarms were given.A ventilator failure was displayed.The ventilation could be continued manually.No injury reported.

• Brand Name: FABIUS MRI
• 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: 14944639
• MDR Text Key: 297604388
• Report Number: 9611500-2022-00157
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K072884
• 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: 08/26/2022

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 Catalogue Number: 8607300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2011
• 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