MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number C30

Device Problem Inflation Problem (1310)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/17/2018

Event Type  Injury  

Event Description

It was reported that the patient had been anesthetized and a nasal endotracheal tube had been inserted.When the tube was checked that it was in right position and level, it was not possible to manually ventilate the patient with the anesthesia workstation.The manual breathing bag didn¿t inflate properly.The patient saturation level decreased to 80 % and the patient was bagged.There was no problem to ventilate the patient with the resuscitator and the patient saturation level rose fast.The ventilation issue with the patient was corrected and the patient was connected to the anesthesia workstation again without further issues.The final patient outcome was no injury.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The anesthesia workstation was investigated on-site by our field service engineer, no fault was found.The safety valve solenoid and upper part including membrane were replaced as a precautionary measure and returned for investigation.Simulated use test of the returned parts mounted in a test system could not reproduce any failure and electrical measurement of the safety valve solenoid found no deviations.The returned parts were found faultless.Evaluation of the logs show that the case was started in manual ventilation with the apl (adjustable pressure limit valve) set to sp (spontaneous breathing) which means that the manual breathing bag fills slowly up to 2 cmh2o apl pressure.The ventilation mode was then set to automatic ventilation and alarms for regulation pressure limited and airway pressure high were generated.These alarms show that a flow was delivered by the system but it was limited by the set airway pressure alarm limit.The ventilation mode was then switched to manual ventilation and the generated alarms indicate that it was during this time the patient was disconnected from the system.After patient reconnection to the system and automatic ventilation was started the case continued without further issues.The system checkout prior to and after the event passed without deviations.There is no indication in the logs of a technical failure in the anesthesia workstation at the time for the event.The root cause of the event has not been determined.(b)(4).Ref.Exemption #: e2018003.(b)(4).

Event Description

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

• Brand Name: FLOW-I C30
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 7252033
• MDR Text Key: 99366089
• Report Number: 8010042-2018-00064
• 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: 05/22/2018

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: C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening