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

Model Number SERVO-AIR

Device Problem Output Problem (3005)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 02/10/2021

Event Type  Injury  

Event Description

Patient was being ventilated with a servo vent, spontaneously stopped delivering minute volumes causing the patient to have elevated respiratory rates, low blood pressure and low heart rate until a replacement was made available.The final patient outcome was no injury.Manufacturer's ref.#: (b)(4).

Event Description

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

Manufacturer Narrative

The investigation consisting of an examination of the ventilator and an evaluation of the ventilator¿s logs has been completed.The field service engineer examined the ventilator.No problem was found, all pre-use checks were successful and no parts were replaced.The patient circuit had been disposed of therefore it was not examined.The evaluation of the ventilator¿s logs show that prior to the event date all pre-use checks were successful and there are no technical error codes.The internal log starts with ongoing ventilation and although there are nine ventilation periods in addition to the ongoing ventilation it is very likely that it was the same adult patient that was being ventilated due to the very short intervals between the ventilation periods.It is therefore unknown when the patient was first connected to the ventilator.The event is reported to have occurred towards the end of 7 days in the received log from the device in the 10th hour of the last period which was in the ps/cpap (pressure support/ continuous positive airway pressure) mode of ventilation.Apart from the clinical alarms and parameter adjustments a times, ventilation ran smoothly until the occurrence of the alarm ¿patient circuit disconnected¿ was generated.This alarm was followed by other alarms that included ¿check tubing¿, ¿peep low¿, ¿expiratory minute volume low¿, ¿air way pressure high¿ and ¿respiratory rate high¿.There are also operator actions that included silencing of alarms, adjustment of oxygen concentration and o2 boost activation.This troublesome period lasted 9 minutes until the ventilator was set to the standby mode.The alarm ¿patient circuit disconnected¿ indicate excessive leakage and all the following alarms were a consequence of this leakage.The logs further show that leakage was nonexistent at 0.0 l/min prior to the event and rose suddenly to total leakage of 99% from this time.At the same time the expiratory minute volume decreased from a stable 9-12 l/min to less than 1 l/min while the respiratory rate increased from a stable 20 -25 b/min to 30 -55 b/min.The evaluation of the device logs confirms the reported issue of a sudden stop in delivered volumes and high respiratory rate.The cause was excessive leakage in the patient circuit that occurred at the time leading to no ventilation of the patient.The patient circuits was disposed of and therefore has not been investigated.There was no ventilator malfunction at the time.The ventilator functioned as set and alarmed appropriately for the leakage that occurred.

• Brand Name: SERVO-AIR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 11357573
• MDR Text Key: 232797115
• Report Number: 3013876692-2021-00015
• 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: 06/02/2021

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 Model Number: SERVO-AIR
• Device Catalogue Number: 6882000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2021
• Distributor Facility Aware Date: 06/01/2021
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening