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

Model Number FLOW-I C20

Device Problem Output Problem (3005)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/05/2021

Event Type  Injury  

Event Description

It was reported that during the start of a patient treatment, there were issues with ventilating the patient and the patient´s saturation level decreased to between 75 and 79%.The patient was placed on an ambubag.The final patient out come is unknown.Manufacturer´s ref #:(b)(4).

Event Description

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

Manufacturer Narrative

Our company field service engineer visited the hospital and investigated the anesthesia workstation.The breathing circuit was found to be incorrectly mounted.A coaxial type of breathing hose with a manual breathing bag was connected to the inspiratory side and the expiratory side of the patient cassette.A single patient hose was connected to the manual ventilation outlet of the patient cassette with an expiratory filter and the sampling line at the other end of the hose.It is likely that the patient was connected to this hose.After connecting the hoses properly, a system check out was successfully performed and the anesthesia workstation worked as intended.The reported difficulties with ventilation the patient could be verified in the received logs.The test log show that a successful system check out was performed in the morning prior to the event.A system check out would not have been possible to perform successfully with this circuit setup.It must have been a different setup during the system check out.Conclusion the reported event was caused by a user mistake.The breathing circuit was mounted incorrectly.The anesthesia workstation had no technical malfunctions during the event.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 11327781
• MDR Text Key: 234277818
• Report Number: 3013876692-2021-00012
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FLOW-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2021
• Distributor Facility Aware Date: 04/12/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2021
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening