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

Model Number SERVO-I

Device Problems Leak/Splash (1354); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2021

Event Type  malfunction  

Event Description

It was reported that there was a leakage noise from the gas module in the ventilator.There was no patient involvement.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The ventilator was investigated on site and the oxygen gas module was diagnosed to be the cause to the reported event.However the customer decided to repair the unit by them self/third part service.No log files have been received.If this fault happens during ventilation, the patient may receive an amount of oxygen in the gas mixture that deviate from the expected.Flow and pressure may also deviate from the expected.Alarms will be activated if the failure occurs during ventilation.As no goods or log files were returned for investigation, the cause of the reported failure could not be determined.

Event Description

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: 11299899
• MDR Text Key: 230991653
• Report Number: 8010042-2021-00300
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1