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

Model Number SERVO-I

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

The ventilator was investigated by our field service engineer (fse).The ventilator failed pressure transducer test during pre-use check.The nozzle unit in the o2 gas module was found to be damaged.After the nozzle unit was replaced, the ventilator was tested, passed pre-use check and was returned for clinical use.The replaced nozzle unit was not returned for investigation.The provided logs confirmed the reported pressure transducer test failure at the event date.No alarms or technical error has been generated at the event date.The nozzle unit is part of the gas module and regulates the inspiratory gas flow to the patient.It consists of a membrane, a mouthpiece and a feather spring.The membrane in the nozzle unit is pressed against a mouthpiece with a feather spring to regulate the gas flow through the gas module.Since the nozzle unit was not returned for investigation, the root cause for how the nozzle unit became damaged could not be determined.

Event Description

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

• Brand Name: SERVO-I
• 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: 11384519
• MDR Text Key: 233741504
• Report Number: 8010042-2021-00504
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1