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

Model Number SERVO-S

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2021

Event Type  malfunction  

Manufacturer Narrative

The ventilator was investigated on-site by our field service engineer.It was not possible to duplicate the reported event.The ventilator passed all safety and functional tests and was cleared for clinical use.Provided ventilator logs were reviewed.There are several alarms for high airway pressure, regulation pressure limited, low expiratory minute volume and high respiratory rate.The generated alarms indicate a high expiratory resistance.With a high expiratory resistance the patient may not be able to fully expire under the expiration phase before initiation of a new inspiration phase which will lead to the above alarms.The pressure level required to achieve the set target volume cannot be delivered and results in that the patient is not sufficiently ventilated.The difficulties may either be related to not optimal user settings of the device for the actual patient or an increased expiratory resistance due to accessories in the patient circuit.Information concerning what type of patient breathing circuit or filter that was in use at the time was not provided.The technical log did not contain any technical error codes that could indicate a malfunction of the ventilator.Successful pre-use check was performed prior and after the event.The root cause is not conclusively determined.There is no indication of a ventilator malfunction at the time of the event.

Event Description

It was reported that the patient was unable to exhale.There was no patient harm.Manufacturer¿s ref #: (b)(4).

• Brand Name: SERVO-S
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11470104
• MDR Text Key: 239401645
• Report Number: 8010042-2021-00547
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1