MAUDE Adverse Event Report: SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. FABIUS PLUS; ANESTHESIA UNITS

Catalog Number 8606800

Device Problem No Pressure (2994)

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

Event Date 02/02/2023

Event Type  malfunction  

Event Description

It was reported that the device posted an alarm during use and that the users decided to replace the device in a controlled maneuver in abundance of caution.No patient consequences have occurred.

Manufacturer Narrative

A draeger fse was dispatched to repair the device and the root cause was traced back to a stuck pump filter with dirt.Replacement of the filter could solve the problem.The auxiliary vacuum pressure is needed to actuate the valves that control the ventilation and to keep the ventilator diaphragm in place during piston movement.With a vacuum pressure out of range the control of the ventilation cycles may be disturbed significantly.The device is subject to routine service and maintenance activities whereby the pump performance will be checked and, a re-calibration will be performed if necessary.Complaint data demonstrates that the inlet filter of the pump is often not checked/replaced as recommended ¿ if it becomes clogged the performance of the pump decreases.

• Brand Name: FABIUS PLUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD.; 230 xin jin qiao road; shanghai ; CH
• Manufacturer (Section G): SHANGHAI DRAEGER MEDICAL INSTRUMENTS; building 3, no.229 hupo rd; szhoupu town; shanghai 20132 1 PR; CH 201321 PRC
• MDR Report Key: 16563763
• MDR Text Key: 311710212
• Report Number: 3019545235-2023-00003
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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