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

Model Number SERVO-I

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Hypoventilation (1916); Low Oxygen Saturation (2477)

Event Date 11/04/2020

Event Type  Injury  

Event Description

It was reported that during patient treatment in nava (neurally adjusted ventilatory assist) mode of ventilation, there was a loss of edi signal and the ventilator went to backup ventilation.The ventilator settings were reportedly not preserved.The ventilator imposed a flow cutoff and a pressure increase.The patient had hypoventilation, hypoxemia and arrhythmia.Final patient outcome is unknown.The edi catheter is a single use feeding tube with measuring electrodes for picking up edi signals during nava ventilation that are used to control the ventilator and assist the patient's breathing in proportional to and in synchrony with the patient¿s own efforts.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

No service was requested and no parts were replaced and returned for investigation.Therefore, the investigation consists of an evaluation of the ventilator logs and information that was received.Provided ventilator logs shows that the alarm edi monitoring not active was generated on the reported event date.The ventilator then switch to backup ventilation.Ventilation mode was thereafter by the user switched to prvc (pressure regulated volume control) with a set tidal volume of 25 ml with an inspiratory rise time set to 5%.Alarms for respiratory rate low and regulation pressure limited were shortly after generated.The tidal volume and inspiratory rise time are adjusted by the user but without result.In prvc ventilation mode the ventilator delivers a pre-set tidal volume and the pressure is automatically regulated to deliver the pre-set volume but it is limited to 5 cm h2o below the set upper pressure limit.The regulation pressure limited alarm is generated when the set volume is not attained due to the imposed restriction of the set upper pressure limit (-5 cm h2o).The high pressure alarm is generated when the upper pressure limit is reached whereby the inspiration phase is terminated and goes over to expiration phase.Ventilation mode is then switched back to nava where the alarm edi monitoring not active was again generated.Ventilation mode was by the user switched to prvc and alarms for regulation pressure limited are again generated.There are no technical error codes in the logs that could indicate a malfunction of the ventilator.The difficulties in ventilating in prvc mode is most likely patient related where the patient is resisting against the ventilator during inspiration.There is no indication of a ventilator malfunction at the time of the event.H3 other text: 4117.

Event Description

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

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10835502
• MDR Text Key: 216094678
• Report Number: 3013876692-2020-00058
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Distributor Facility Aware Date: 09/30/2021
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2021
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 5