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

Model Number 8607300

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Electrical Overstress (2924)

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

Event Date 07/14/2022

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 the ventilator stopped during use of the device.It was mentioned that no consequences to the patient have resulted from that; patient support was done in maunal ventilation.

Event Description

It was reported that the ventilator stopped during use of the device.It was mentioned that no consequences to the patient have resulted from that; patient support was done in manual ventilation.

Manufacturer Narrative

The device was inspected by a dräger service engineer.Based on the findings of an initial log file analysis it was decided to replace the upper piston diaphragm and the pump that generates the auxiliary vacuum pressure.The device was tested afterwards, found fully compliant to specifications and could be returned to use.A detailed log file analysis carried out by the manufacturer confirms the validity of the initial expertise and the appropriateness of the repair measure.The log contains entries demonstrating that the driving current for the ventilator motor went repeatedly up to a range where it will be switched-off by the supervisor function of the software to prevent from damages to the ventilator unit.The shut-down of ventilation was accompanied by a corresponding alarm; manual ventilation with the built-in breathing bag remains possible then.A plausible explanation would be that the upper piston diaphragm became dislodged or wrinkled and hindered the piston in its movement which resulted in an increase of the motor current above the allowed threshold.The piston diaphragm is kept in place by a vacuum pressure generated by a dedicated pump - it would be feasible that a decrease in the vacuum pressure contributed to a dislocation or wrinkling of the diaphragm.Finally, it can be concluded that the device has responded as designed upon this particular error condition; the device was ready to use again after all parts had been replaced that can be put in causal connection to the symptoms.

• 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: 15291348
• MDR Text Key: 304011145
• Report Number: 9611500-2022-00218
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)211215(17)220307(93)8607300-49
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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: 8607300
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2021
• 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
• Treatment: N/A.; N/A.