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

Model Number C30

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015 02:13 pm (gmt-5:00) added by (b)(6) ((b)(4)): more information surrounding the event has been sought.A supplemental medwatch report will be provided when the investigation is finished.

Event Description

It was reported that while on patient, the anesthesia system delivered little or no flow when the o2 flush button was pressed.There was no patient harm.Manufacturers reference # : (b)(4).

Manufacturer Narrative

The anesthesia system was investigated on-site by the hospital biomedical engineer.No fault was found and no parts were replaced.The device logs were downloaded and sent for evaluation.Evaluation of the received device logs shows that the system checkout prior to and after the reported event passed without deviations.The technical log has no entry on the date of event.The event log shows that the case was started in manual ventilation with the apl (adjustable pressure limit) set to sp (spontaneous breathing) which means that the system is fully open and the patient is expected to breathe by himself.With apl set to sp the manual bag will fill slowly and it can be perceived as not possible to ventilate the patient.After a few minutes the apl setting was adjusted to 28 cmh2o.The trend log shows very small inspiratory and expiratory tidal volumes and a negative measured mean pressure during the first minutes of the case which indicates that no flow actually was delivered into the breathing system.This results in a negative flow/pressure during the gas sampling.Prior investigations have found that a stuck one way valve in the inspiratory valve may lead to the reported issue and in this case it may have been only weakly stuck but was loosened when the apl pressure were increased.Since no parts were replaced or confirmed faulty the cause of the reported problem has not been determined.

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: 5310957
• MDR Text Key: 34616622
• Report Number: 8010042-2015-01103
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

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 Model Number: C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2012
• 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