• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. FABIUS PLUS XL; ANESTHESIA UNITS Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18381632
MDR Text Key331227439
Report Number3019545235-2023-00022
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K011404
Number of Events Reported1
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 Number8608555
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2023
Initial Date FDA Received12/22/2023
Supplement Dates Manufacturer Received12/26/2023
Supplement Dates FDA Received02/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-