MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I; GAS-MACHINE, ANESTHESIA

Model Number FLOW-I C20

Device Problem Failure to Deliver (2338)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/11/2020

Event Type  Injury  

Event Description

It was reported that while in use on a patient, the anesthesia workstation did not provide any gas.The patient saturation decreased to 56 % (lowest value).An ambubag had to be introduced with which the patient's saturation was quickly corrected.There was no patient harm.Manufacturer´s ref #: (b)(4).

Event Description

Manufacturer's reference #: (b)(4).

Manufacturer Narrative

The anesthesia workstation (hereafter called the system) was investigated by the local field service engineer (fse) and no faults or deviations were found.The received information from the hospital, the investigation by the fse and received logs suggest that the reported event was caused by the user not starting the ventilation (believing that the system was in automatic ventilation mode) when the system was set to manual ventilation mode.When the system had been turned to off by using the emergency ventilation switch (emergency ventilation did not work either according to the user), the system was restarted and when the automatic ventilation was started shortly thereafter, the anesthesia workstation worked as intended and the surgery could continue for approximately 3-4 hours without any issues.The system has been returned to clinical use without any faults reported ever since.Our conclusion is that the reported event was related to the user.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10418776
• MDR Text Key: 203284369
• Report Number: 8010042-2020-00536
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening