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

Catalog Number 6694800

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Cardiopulmonary Arrest (1765); Loss Of Pulse (2562)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had become disconnected from the circuit.The patient was using the f & p high flow set, with the white bing removed and a green connector used to connect the two.The patient was fully monitored with all the required monitoring devices.The patient central monitoring alarms were going off however all of the staff were busy dealing with other patients and were unable to attend to the patient.When the staff did attend to the alarms the patient was found in a pulse less state and a crash call was raised and the necessary protocols were followed.The patient¿s final outcome is unknown.Manufacturer reference#: (b)(4).

Manufacturer Narrative

No parts were replaced therefore the investigation consists of an evaluation of the logs and information from the hospital.The evaluation of the logs shows that they do not contain anything that suggests that there was a ventilator malfunction at the time.The ventilator functioned as set in the high flow therapy mode of ventilation.In the high flow therapy mode of ventilation the ventilator delivers a set flow of heated and humidified gas with a set concentration of oxygen to the patient who must be breathing spontaneously.The connection to the patient is by the high flow nasal cannula or tracheostomy interface.The ventilation mode has limited alarms where most of the other alarms are not available.The user is always advised to use external monitoring.The mode of ventilation by itself is a disconnection providing a continuous flow with no expiratory flow being returned to the ventilator which implies that there cannot be a disconnect alarm.The conclusion is that there was no ventilator malfunction at the time.There was no disconnection alarm to expect because it is not available.The cause was the circuit with the nasal cannula that was being used to deliver the high flow.The connector was tight at start of connection but got very loose during use and got disconnected when the circuit was heated and humidified.External monitoring was in use as recommended and it alarmed but the alarms were not attended to.

Event Description

Manufacturer reference#: (b)(4).

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 8491245
• MDR Text Key: 141189087
• Report Number: 8010042-2019-00245
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K108898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6694800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 07/05/2019
• Supplement Dates FDA Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening