MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-S; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number SERVO-S

Device Problem Output Problem (3005)

Patient Problem Death (1802)

Event Date 12/22/2020

Event Type  Death  

Event Description

It was reported that during ventilation of a patient, the ventilator alarmed for expiratory cassette failure.The patient was moved to another ventilator.When the patient was connected to the new ventilator the patient presented a significant hemodynamic instability, drop in saturation, bilateral subcutaneous emphysema and bilateral voiding murmur.Bilateral chest drain needed.The patient died due to hemodynamic and ventilatory instability about 12 hours after the complication.Manufacturer¿s ref.#: (b)(4).

Event Description

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

Manufacturer Narrative

Our fse (field service engineer) arrived at the hospital the day after the event for investigation of the ventilator.The ventilator was not available since it had been returned for clinical use and was in use with a new patient.On (b)(6) 2021 our fse got access to the ventilator.The device logs were downloaded and a successful pre-use check with a new expiratory cassette was performed.Additional information about the patient saturation levels during the event, and what measures that were taken for the ventilator before it was put back into clinical use after the event were requested from the user facility, but no further information has been received.Evaluation of the logs confirm that several alarms for technical error in expiratory cassette were generated since two months before, on and after the date of event.Several alarms for technical error in expiratory cassette were generated on the date of event but the exact time of the reported event was not given.The log shows that no successful pre-use check was performed before the ventilation period when the event occurred, was started.The last successful pre-use check was performed more than one month before the event.2 days before the event a pre-use check was started and that failed.The pre-use check test was not completed and no new pre-use check was performed.The first pre-use check after the event date was performed on (b)(6) 2021, with a new expiratory cassette installed, and it was successful.Since the ventilator was continued used after the event the event log for the date of event has been overwritten by new log posts.The expiratory cassette is a measuring device for the expiratory gas flow.The expiratory cassette can be removed for cleaning or be interchanged between different systems.A pre-use check is always required after exchanging the expiratory cassette.A failure in the expiratory cassette will not affect delivered flow and pressure to the patient that will be as set but it may affect the expiratory gas flow measuring in a way that the displayed measured values are incorrect.Our conclusion is that the technical error in expiratory cassette occurred as reported on the day of the event, and the cause of the alarm is concluded to be a faulty expiratory cassette.Since it was a recurring error the last two months it cannot be regarded as a new issue on the date of the event.The alarm does not affect delivered gas mixture values during ventilation but only the measuring of expiratory gas flow measuring.The alarm is a high priority alarm that can only be silenced for two minutes and according to the received information this was the cause of removing the ventilator from use.The reported patient incident was according to the user facility a consequence of the need to replace the ventilator but the circumstances around the removing of the ventilator, how the patient was ventilated during the removing of the ventilator and why the patient general condition deteriorated is unknown.The cause of the reported patient incident has not been determined in this investigation.

• Brand Name: SERVO-S
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 11193285
• MDR Text Key: 227503238
• Report Number: 3013876692-2021-00005
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-S
• Device Catalogue Number: 6640440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2021
• Distributor Facility Aware Date: 03/23/2021
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2021
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Weight: 46