MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20; GAS-MACHINE, ANESTHESIA

Model Number C20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

It was reported that in the beginning of the surgery when the procedure had started the patient started to moan and move arms.The patient pulled the lma (laryngeal mask airway) out.The patient was administered an anesthetic agent and was re-intubated.The patient awareness level increased and awoke.The final patient outcome was no injury.Manufacturer's ref #:(b)(4).

Event Description

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

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #: e2018003 getinge usa sales, llc (b)(4).Contact person: (b)(6).No fault was found when the device was examined at the hospital.There are no technical errors/alarms in the received device logs.System check out passed prior to and after the event.The trend log contains no data since the logs were saved more than 24 hours after the event.The internal log shows that the patient was ventilated without having any sevoflurane added to the fresh gas.The vaporizer was either set to off (in manual ventilation) or no target value was selected in agc.Apart from this, there is nothing else that would explain the reported lack of agent delivery.If the vaporizer would have been shut down by itself or by the system, alarms/technical errors would have been generated.Our conclusion based on the device log evaluation and the received information is that the reported event, that the anesthesia system didn¿t deliver sevoflurane, is related to the user and not a technical failure in the anesthesia system.

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 7743457
• MDR Text Key: 115828910
• Report Number: 8010042-2018-00398
• 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: 10/01/2018

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: C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other