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

Model Number SERVO-I

Device Problem Unintended Collision (1429)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that the ventilator became magnetically attracted to an mri scanner.There was no patient harm.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The ventilator became damaged and was repaired and cleared for clinical use.The ventilator operates in a field of up to 20mt (200 gauss) for tunnel scanners and up to 10mt (100 gauss) for open scanners.Before using the ventilator in the mr environment, conditions must be met, including locking the wheels and placing the ventilator outside the 200 gauss (20mt) safety line, which must be marked around the mr scanner.These conditions are stated in the declaration for the use of the ventilator in the mr environment and are included as part of the "mr environment agreement".According to received information, the safety line was marked around the mr scanner and the ventilator was moved without the brakes locked.Our conclusion is that the incident was caused by the user not following the requirements for use of the ventilator in mr environment.

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: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 18212370
• MDR Text Key: 329251198
• Report Number: 8010042-2023-02294
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• 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: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1