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

Catalog Number 8608555

Device Problems Failure to Deliver (2338); Insufficient Information (3190)

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

Event Date 10/20/2023

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 alarmed with ventilator failure in a machine control situation and no health consequences have reportedly occurred.

Event Description

It was reported that the device alarmed with ventilator failure in a machine control situation and no health consequences have reportedly occurred.

Manufacturer Narrative

It was reported that the device alarmed with ventilator failure in a machine control situation and could not be machine controlled during giving the patient anesthesiaand.There was no patient injury.The maintanence of this hospital was preformed by 3rd party and the user facility did not involve the local dräger s&s organization into examination and repair of the device and, upon contacting the hospital fort the purpose to obtain additional information it was responded that no furhter details can be provided.This does neither allow a case-specific evaluation nor a reliable conclusion in regard to the root cause.According to the report provided by the hospital, the mainframe was later found to be damaged.Its state of maintenance and use was unknown, so the root cause of the accident could not be determined.The anesthesia machine issued an alarm as designed to alert the user, no injuries were reported, and dräger will continue to monitor for similar incidents.

• 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 Key: 18109403
• MDR Text Key: 329227727
• Report Number: 3019545235-2023-00017
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8608555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2019
• 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.