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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. FABIUS PLUS XL; ANESTHESIA UNITS
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SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. FABIUS PLUS XL; ANESTHESIA UNITS Back to Search Results
Catalog Number 8608555
Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)
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.
 
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
It was reported that in jun, during use, the machine 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".After replacing the motor, the problem was resolved.No patient involved.The investigation and test are preformed on the return sample.Based on known information , motor defect will affect automatic ventilation.Then ventilator fail alarm will be generating the appropriate way.Doctor can switch ventilation mode to man/spont (safety mode), so that there will be no injury to the patient.With the investigation could confirmed that the carbon brush or commutator was abnormal wearied.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable for all components in question.Keep on monitoring similar cases.
 
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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 Key18010572
MDR Text Key326590343
Report Number3019545235-2023-00012
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 11/17/2023
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 Received10/10/2023
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
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