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

Device Problem Suction Problem (2170)

Patient Problem Death (1802)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Information regarding, hospital name, hospital address, contact person at hospital, device catalog number, device serial number and device logs were not received.Attempts to get this information are ongoing.(b)(4).

Event Description

Our distributor received information from (b)(6) and forwarded it to us.The information stated that an incident had occurred while the patient was connected to the anesthesia workstation.The information further stated that hospital staff were unable to ventilate the patient after an aspiration had taken place.It was further stated that the patient died as a consequence of that.(b)(4).

Manufacturer Narrative

Further efforts to get information regarding, hospital name and address, contact person at hospital, device catalog number and serial number and device logs have not been successful.Therefore, the involved anesthesia workstation has not been investigated.In the information from the norwegian authority our distributor received an excerpt from a log stating that it was for the time of event (serial number on the device was not showed).A plot diagram of measured ppeak, vte and etco2 for the same time as the excerpt of the log was also received.Evaluation of the excerpt of the log for the given period shows that system checkout performed before case start was successful and there is no recording of technical error alarm to indicate any malfunction of the device.The excerpt of the log shows that the case was in manual ventilation.The apl (adjustable pressure limit) was changed up and down several times during the case and was set between 13 cmh2o and 38 cmh2o.Some alarms for low and high etco2, high fico2 and low fio2 were generated.The generated alarms for etco2 low indicate a low exchange of co2 or a disconnected sampling line.The plot diagram shows that the device delivered a pressure correlating with the apl settings.With the limited received information, the cause of the ventilation issues cannot be determined.(b)(4).Ref.Exemption #: e2018003.(b)(4).

Event Description

(b)(4).

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 7706240
• MDR Text Key: 114569059
• Report Number: 8010042-2018-00370
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death