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

Model Number SERVO-N

Device Problem Output Problem (3005)

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

Event Date 04/14/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator generated a technical error code indicating disabled valves.There was no patient harm.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The ventilator was investigated by our field service engineer.The ventilator passed pre-use check and test ventilation using a test lung.Y sensor was installed and ventilation carried on normally without alarms.The reported event could not be duplicated.The expiratory cassette was precautionary replaced.The ventilator was cleared for clinical use.The replaced part was not returned for investigation.Provided ventilator logs confirms the reported technical error code.Since no parts were returned for investigation, the root cause of the event has not been determined.

Event Description

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

• Brand Name: SERVO-N
• 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: 11751924
• MDR Text Key: 248196779
• Report Number: 8010042-2021-00972
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K180098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-N
• Device Catalogue Number: 6688600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1