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

Catalog Number 8607300

Device Problem Failure to Deliver (2338)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results will be provided in a separate follow-up-report.

Event Description

It was reported that the device would not deliver tidal volume/ pressure.There was no patient injury reported.

Manufacturer Narrative

The investigation was performed based on the available information.The electronic log file was not available.Based on what was reported, the malfunction had already been resolved before the draeger technician checked the device on 2024-03-25.There is no report available for this 3rd party repair.According to the additionally provided information, the pba board got replaced.This explains, why the log file does not show the entries generated during use on the date of event (=2024-03-14).The draeger technician checked the device and performed ipm-l test steps to confirm proper operation, all passed.Replacement of the pba board has obviously fixed the issue.Based on the information available, the root cause could not be determined.The fabius is equipped with integrated pressure-, volume- and o2-monitoring.An alarm will be generated if the measured value is out of adjusted alarm limits (insp pres not reach !!, apnea pressure! apnea flow !!! etc.).H3 other text : device not available for investigation.

Event Description

It was reported that the device would not deliver tidal volume/ pressure.There was no patient 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 19179311
• MDR Text Key: 341007000
• Report Number: 9611500-2024-00178
• 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: 05/29/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 09/24/2015
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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