Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Failure to Deliver (2338); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2023
Event Type  malfunction  
Event Description
It was reported that the machine suddenly gave an alarm "ventilator failure, check apl valve" during usage, and the machine was unable to operate normally.No health consequences have reportedly occurred.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
 
Manufacturer Narrative
It was reported that during use, the machine of usnf-0024 suddenly gave an alarm "ventilator failure, check apl valve", and the machine was unable to operate normally.Upon inspection, an error code was found reporting "v044, v041".No patient injury.In case of a ventilator failure during automatic ventilation, the ventilator initiates an autonomous shutdown while changing mode to man/spont (safety mode) and generating the appropriate ventilator fail alarm.Manual ventilation remains possible.All alarms, possible causes and remedies as well are described in the instructions for use.As the repair has not be completed and the part was not returned for further investigation, it is not confirmed the root cuase.Once the part was returned , the investigation will be updated accordingly.
 
Event Description
It was reported that the machine suddenly gave an alarm "ventilator failure, check apl valve" during usage, and the machine was unable to operate normally.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 Key18010623
MDR Text Key326600251
Report Number3019545235-2023-00013
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 11/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2023
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
Date Manufacturer Received10/30/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.; NA.
-
-