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

Catalog Number 8606800

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 08/24/2023

Event Type  malfunction  

Event Description

It was reported that there was a sudden "ventilator failure" alarm, unable to enter the independent breathing mode.No health consequences have reportedly occurred.

Manufacturer Narrative

It was reported that there was a sudden "ventilator failure" alarm during usage.The automatic mode of the ventilator failed, and it was switched to manual mode to manually ventilate the patient.The patient's vital signs were stable and the surgery went smoothly.No patient injury.The fse visited on site and replaced the pump after trouble shooting, the problem was resolved.The part involved was returned to manufacture for investigation.The investigation and testing were performed on the returned part.1.Measure the input port of the negative pressure pump, and no short circuit or open circuit is found.2.Power on test, first use a lower voltage of 12v, with the sound of the motor rotating, it can be confirmed that the motor and pcb of the motor can work and are functional.3.Then you can hear abnormal noises, as well as the sound of piston and motor rotation being blocked.4.There is a foreign object blocking the movement process of the piston.5.Further disassemble of the piston area, it was found that the shaft sleeve of the piston connecting rod had broken, forming a situation that blocked the piston from running.Draeger finally concluded that the shaft sleeve of the piston connecting rod broken lead to no negative pressure, and micro controller stops the ventilator and makes alarm single on screen and to the louder speaker.The device has alarmed as designed.Besides, based on the maintenance record , the sn of the device involved should be (b)(6), not (b)(6)reported by the hospital.Fabius plus anesthesia device 8606800 sn (b)(6) was first produced and tested in sdmi in dec.2013, and it has been used around ten years.

• 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 INSTRUMENT CO. LTD.; 230 xin jin qiao road; shanghai PRC-2 0120; CH PRC-201206
• Manufacturer Contact: 230 xin jin qiao road; shanghai PRC-2-0120 ; 2131086385
• MDR Report Key: 18451952
• MDR Text Key: 332755550
• Report Number: 3019545235-2024-00001
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• 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
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2023
• 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: NA.