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

Catalog Number 8606800

Device Problems Gas Output Problem (1266); Insufficient Information (3190); Device Handling Problem (3265); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  malfunction  

Event Description

It was reported that vent fail during use, 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 the ventilator was working normally at 12:30, a respiratory alarm occurred at 12:40, the respiration was not in working condition, and after restarting it was still not working properly, manual support respiration was given, and there were no reports of patient injury.Based on the initial confirmation, no report was received that the ventilator did not work, so a field engineer was dispatched to the site to verify the event and download the equipment logs for further analysis.The manufacture analyzed the logs obtained and according to the log files, the device failed on (b)(6) 2023,but the event was not consistent with what was reported to the hospital in adr.The actual malfunction was an error report of a negative ventilator roll film pressure below specification, which was resolved by adjusting the position of the 2600650 component, and no similar problems have occurred to date.This phenomenon is mainly caused by the 2600650 component not being installed correctly after cleaning and disinfecting, i.E., the probable cause is user error.It can be confirmed that the hospital's adr report that ventilator did not work was inaccurately.

Event Description

It was reported that vent fail during use, no health consequences have reportedly occurred.

• 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 Key: 18666596
• MDR Text Key: 334838229
• Report Number: 3019545235-2024-00004
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• 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: 04/03/2024

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 Number: 8606800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/31/2024
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/03/2024
• 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 Number: 1
• Treatment: NA.; NA.