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

Model Number SERVO-AIR

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator failed the pressure transducer test during pre.Use check.There was no patient involvement.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

The ventilator was investigated on site by our service technician.It was reported that the ventilator failed the pre-use check during the pressure transducer test.The fault was isolated to the turbine module which was replaced and returned for investigation.The ventilator passed pre-use check and was cleared for clinical use.Simulated use testing of the received turbine module has reproduced the described customer issue.An evaluation of the received device logs could confirm the event.The failure in pre-use check can be dated to (b)(6) 2021, this will be set as the date of event.A defect turbine in the turbine module caused the unit to fail the pre-use check.Replacement of the turbine resulted in passing the pre-use check.A defective turbine module may lead to a stop of air supply during ventilation.When this error occur, the device will automatically switch to 100% o2 supply.If no o2 is available, the issue will lead to stop of ventilation.The conclusion in this matter is that the reported issue was caused by a faulty turbine in the turbine module.The root cause of the turbine failure has not been determined by this investigation.

Event Description

Manfuacturer ref # (b)(4).

• Brand Name: SERVO-AIR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 11378214
• MDR Text Key: 233487566
• Report Number: 8010042-2021-00497
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K192604
• 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: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1