MAUDE Adverse Event Report: MAGNUS LINDQVIST SERVO-U; VENTILATOR, CONTINUOUS, FACILITY USE

Catalog Number 6694800

Device Problem Improper Flow or Infusion (2954)

Patient Problem Respiratory Acidosis (2482)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while the ventilator was connected to a patient, the patient began to have increasing etco2 to the 70-90s, stacking breaths and total peep from auto peep.It was further stated that it appeared as if the valve was not opening to allow exhalation.The measured tidal volume was half the inhaled volume.The patients ph was 7.19 and co2 was 95.The ventilator was disconnected from the patient and the patient was bagged.The ventilator was replaced with another one.Ventilation with the new ventilator with same settings was without any problems and the patient was breathing comfortably.The patients etco2 decreased to the 50s.The final patient outcome was no injury.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption #: e2018002.Importer- maquet medical systems usa 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).Additional information that was received from the user states that the day after the event the user reproduced the reported failure during simulated use test of the ventilator with the breathing circuit used at the time of the event.The user determined that the cause of the failure was the expiratory filter that was occluded.The expiratory filter is not manufactured or distributed by us.Our field service engineer was dispatched to the site for investigation of the device.No fault was found and no parts were replaced.The device logs were downloaded and the ventilator was returned back for clinical use.Evaluation of the received device log shows that pre-use check prior to and after the event was successfully performed.The logs including the trend log confirms a high airway pressure situation during the last hours of ventilation.The high measured peep is an indication of that the patient was not able to complete exhale during expiration due to an increased expiratory resistance.This situation leads to that a lower tidal volume than intended can be inspired.Our conclusion, based on the information received from customer and evaluation of the received device logs, is that the cause of the event was an occluded expiratory filter.There was no technical failure with the ventilator at the time of event.

Event Description

Manufacturer reference#: (b)(4).Importer reference #: (b)(4).

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• MDR Report Key: 7772940
• MDR Text Key: 116771033
• Report Number: 8010042-2018-00417
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K151814
• 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: 07/19/2018,02/26/2019

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 Catalogue Number: 6694800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/19/2018
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2018
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening