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

Catalog Number 8608555

Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that the device suddenly black screen and shut down during usage ,no health consequences have reportedly occurred.

Manufacturer Narrative

It was reported that the patient on (b)(6) 2023 in our hospital anesthesiology department using anesthetics for surgical treatment, in the process of surgery suddenly black screen and shut down.No patient injury reported.After investigation, according to the analysis of the logs of 4th december, the anesthesia machine ran for 7 minutes on internal battery power (it was not sure that the battery was fully charged or not).From the logs of 11th december, the anesthesia machine ran for 2 minutes on internal battery power (it was not sure that the battery was fully charged or not).The power supply to the hospital's operating room is frequently interrupted (either artificially or accidentally).An internal battery low battery alarm was recorded during this time, which indicated that the device responded as designed.Fabius plus xl anesthesia device 8608555 sn (b)(6) was first produced and tested in sdmi in aug.2014.It has been used in hospital for more than nine years.The built-in internal battery is a consumable part, which needs to be replaced periodically according to the age and frequency of use (for maintenance measures, the ifu has instructions for periodic maintenance and replacement of the internal battery).Batteries are required to be exchanged every 3 years during maintenance.According to the instructions for use, the new internal battery (when it was full charged) can support the operation of the device for at least 40 minutes.The short operating time of the internal battery could be due to the age of the battery and lack of maintenance and/or replacement, or because the internal battery was not fully charged.Draeger concluded that this is not a technical failure, the built-in internal battery is a consumable part, when used for many years without maintenance and/or replacement, after natural degradation of battery performance has occurred, battery-powered usage time will be shortened.

Event Description

It was reported that the device suddenly black screen and shut down during usage ,no health consequences have reportedly occurred.

• Brand Name: FABIUS PLUS XL
• 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: 18381632
• MDR Text Key: 331227439
• Report Number: 3019545235-2023-00022
• 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: 02/05/2024

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: 8608555
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2014
• 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