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

Model Number SERVO-U

Device Problem Output Problem (3005)

Patient Problem Hypoventilation (1916)

Event Date 06/24/2020

Event Type  Injury  

Event Description

It was reported that while the ventilator was connected to a patient in the simv (pc) + ps (synchronized intermittent mandatory ventilation (pressure control) +pressure support) mode of ventilation, the patient¿s etco2 was 14 kpa and saturation was 87 %.The patient¿s rr dropped to 6 bpm.The patient was distressed, sweating and clammy and was nasal flaring.The backup rate of 12 bpm did not begin therefore the patient was bagged and the etco2 decreased to 5-6kpa.The ventilator was replaced and patient's values were back to normal.The final patient outcome was no harm.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

The type of reportable event in follow-up #1, section h1 was inadvertently check as ¿malfunction¿.It has now been corrected to ¿serious injury¿.

Event Description

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

Manufacturer Narrative

The investigation into this complaint has been completed.No parts were replaced therefore the investigation consists of an evaluation of the logs from the ventilator and information that was received from the hospital.The logs show that ventilation in simv (pc) +ps had been on-going for 2 days until the occurrence of the event towards the end.The logs show that at the time of the event there was a frequency drop from about 20 b/min to 15 b/min (the set simv rate) and from being mostly spontaneous breaths to mainly controlled simv breaths.The peep and pmean increased and the tidal volume decreased.Peep increased from 8 to about 11 cmh2o, pmean from 12 to about 14 cmh2o and tidal volume decreased from about 210 to 130 ml.Consequently the minute volume dropped from about 4 to 2 l/min.It appears that the patient got a respiratory arrest and the only breaths delivered were simv breaths.There may have been an increased expiratory resistance in the breathing circuit (e.G.An occluded filter) that led to the decrease in spontaneous breathing and tidal volume and increase in peep and pmean.There was no drop in respiratory rate below 15 b/min in simv mode.Later the mode of ventilation was changed to pressure support/cpap.There are ¿no patient effort alarms¿ and ¿patient-initiated return to supported ventilation¿ indications that confirm the patient¿s respiratory arrests that were causing the ventilator to step in and provide backup ventilation.The patient had periodical respiratory arrests during the last 1.5 hours of ventilation.In the simv (pc) + ps mode of ventilation this meant that, the patient received only the set mandatory breaths of 15 b/min without spontaneous breathing.The received volumes were not adequate compared to the received volumes before this period.The conclusion in the matter is that there was no ventilator malfunction at any given time.The ventilator functioned as it should and delivered breaths according to the set parameters and had nothing to do with the deterioration of the patient¿s condition.The cause was instead the periodical respiratory arrests and decrease in received volumes that the patient was experiencing.There was no decrease in respiratory rate below the set controlled breaths in simv.The facility examined the ventilator.

Event Description

Manufacturer's ref.#: (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: 10229437
• MDR Text Key: 197570588
• Report Number: 8010042-2020-00394
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K180098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-U
• Device Catalogue Number: 6694800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening