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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. ATLAN A350/A350 XL CC; ANESTHESIA UNITS

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SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. ATLAN A350/A350 XL CC; ANESTHESIA UNITS Back to Search Results
Catalog Number 2600000
Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2023
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 had automatically switched from manual mode to standby several times in the past, no health consequences have reportedly occurred.
 
Manufacturer Narrative
It was reported that ventilator failure during usage, and sometimes the device had automatically switched from manual mode to standby no patient injury reported.After log analysis, two errors and recommendation were given as below.1.2023 (b)(6) 09:43:13 pressure sensor blocked or not connected.This may be caused by a blocked gas supply line, please help by checking that the supply line is properly connected to the negative pressure sensor on the pba board and that the supply line is not bent.2.2023 (b)(6) 09:43:13 incremental encoder error.This fault could lead to malfunction of the motor, and may cause the failure of mechanical ventilation mode.Please perform the ventilator test in the hit software.Attempt to carry out a referencing on the hit page "a350 core unit/ventilator and breathing system/ventilator" from the description of the service engineer, no more actions they have done and no failure reproduced anymore.No more investigation could be done due to lack of more information.The root cause was not confirmed.
 
Event Description
It was reported that the device had automatically switched from manual mode to standby several times in the past, no health consequences have reportedly occurred.
 
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Brand Name
ATLAN A350/A350 XL CC
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 Key18433833
MDR Text Key331931707
Report Number3019545235-2023-00008
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K230931
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 02/16/2024
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 Number2600000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/21/2023
Initial Date FDA Received01/03/2024
Supplement Dates Manufacturer Received01/24/2024
Supplement Dates FDA Received02/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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