MAUDE Adverse Event Report: FLOW-I-C20; GAS-MACHINE, ANESTHESIA

Catalog Number 6677200

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that the anesthesia workstation measured a higher fico2 level than expected during an extended time period.There was no patient harm.(b)(4).

Manufacturer Narrative

The anesthesia workstation was investigated by the hospital biomedical engineer.At the start of investigation/test, the measured fico2 was about 10 mmhg.30 minutes later, the measured fico2 was close to zero.No parts were replaced.Evaluation of the received device logs can confirm the reported fico2 high alarms.The logs show further that the co2 absorber was bypassed and docked in place on three occasions and that the patient cassette was disconnected and replaced on two occasions, most likely during attempts to solve the high fico2 readings.The water trap shall be replaced at least every 30 days as stated in the user's manual.The filter in the water trap show a degradation in hydrophobic properties over time when it is used.This will be indicated by a larger pressure drop at moist conditions, and effects the co2 reading.It is unclear how long time the water trap had been in use at the time of the event.The root cause to the reported event has not been determined.

Event Description

Manufacturer's ref #:(b)(4).Importer's ref #: (b)(4).

• Brand Name: FLOW-I-C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• MDR Report Key: 8524605
• MDR Text Key: 142351512
• Report Number: 8010042-2019-00270
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

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: 6677200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1