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

Catalog Number 8606800

Device Problems Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338); Data Problem (3196)

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

Event Date 12/15/2023

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 that the equipment was found not machine controllable, no health consequences have reportedly occurred.

Manufacturer Narrative

It was reported that the equipment was not machine controllable without causing any injuries.After investigation, when the motherboard's built-in lithium (coin) battery has failed (expired ram battery), there will be loss of all calibration data.And will lead to software stops automatic ventilation due to loss of calibration data.There was no calibration data as the operational parameters of the fabius software, therefore fabius plus stops automatic ventilation.Software then will issue vent fail alarm.Written in ifu: replacement of ram battery every 3 years as part of periodic maintenance.Fabius plus anesthesia device 8606800 sn (b)(6) was first produced and tested in sdmi in may.2009, and has been used in hospital more than ten years.The maintenance and the usage conditions are unknown.It was possible that the user failed to (regularly) maintain and replace the coin cell batteries on the main board as required by the ifu.The user facility should perform the maintenance in a timely manner and in accordance with the requirements of the manual.This was the second event of the same devcie, the first event was handled with (b)(4).

Event Description

It was reported that that the equipment was found not machine controllable, no health consequences have reportedly occurred.

• 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: 18433890
• MDR Text Key: 331902201
• Report Number: 3019545235-2023-00014
• 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,Followup
• Report Date: 02/16/2024

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: 8606800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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.; NA.