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 02/04/2021

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The issue was confirmed in the provided service report, and was resolved by cleaning the inspiratory pipe and expiratory cassette membrane.It is recommended that a complete cleaning of the system should be performed before carrying out preventive maintenance.The reported issue is detected during the mandatory pre-use check, or by various alarms if active during ventilation.No device malfunction has been established, the issue is related to the cleaning and maintenance procedures.

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: 11377116
• MDR Text Key: 234829999
• Report Number: 8010042-2021-00485
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

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-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• 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