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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. FABIUS PLUS; ANESTHESIA UNITS
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SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. FABIUS PLUS; ANESTHESIA UNITS Back to Search Results
Catalog Number 8606800
Device Problems Circuit Failure (1089); Failure to Conduct (1114); Gas Output Problem (1266); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2023
Event Type  malfunction  
Event Description
It was reported that on (b)(6) 2023, the anesthesia machine suddenly did not work during usage on patient on no.842 bed who was under general anesthesia for "lumbar spine fracture incision and restoration internal fixation.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 on (b)(6) 2023, the anesthesia machine suddenly did not work during usage on patient.No patient injury.After confirming with the fse in sep, it was the pba control ii ((b)(4) ) caused the device malfunction.The quotation of the pba has provided to the hospital , waiting for the customer's reply.After confirming with the fse on 2023-11-13, the engineer from hospital resolved the problem by themself, didn't involve draeger.Based on the information, the root cause of the pba control ii could not be confirmed.The anesthesia machine was manufactured in 2010 and had been in use for 12 years,failure is possible due to wear or material fatigue of some components.; its maintenance and use were unknown, so the root cause of the accident could not be determined.If the sample returned, test lab will test returned pcb, and the root cause is to be investigated.Based on there was no returned parts, further analysis cannot be conducted.
 
Event Description
It was reported that on (b)(6) 2023, the anesthesia machine suddenly did not work during usage on patient on no.842 bed who was under general anesthesia for "lumbar spine fracture incision and restoration internal fixation.No health consequences have reportedly occurred.
 
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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 Key17815868
MDR Text Key324216990
Report Number3019545235-2023-00007
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 11/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8606800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date09/14/2023
Date Manufacturer Received10/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2010
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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