MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-I; SUPPORT, ARM

Model Number SERVO-I

Device Problem Mechanical Problem (1384)

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

Event Date 08/11/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator's support arm was broken.There was no patient harm.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

It was claimed that the repair of support arm is requested.Identification of issue has been done by analyzing problem description.There was no patient harm.Based on the information collected to date, it has been clarified that clamp mount has been damaged by wear caused by use.The clamp mount is a part of support arm and is mounted directly to the servo device.The support arm serves to relieve the patient from the weight of the tubing system.When moving the support arm or changing position, the patient connection should be observed to see that no pulling or other movement occurs.The issue was decided to be reported as broken/damaged support arm may lead to stop of ventilation (extubation) or injury.The root cause to the reported issue has not been determined.The correction of fields #h4 device manufacture date and #h8 usage of device was required.This is based on the internal evaluation.#h4 manufacture date: previous manufacture date: 03/26/2017.Corrected manufacture date: 03/20/2017.#h8 usage of device: previous usage of device: unknown.Corrected usage of device: reuse.

Event Description

Manufacturer's ref.#: (b)(4).

• Brand Name: SERVO-I
• Type of Device: SUPPORT, ARM
• 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: 12427644
• MDR Text Key: 270074333
• Report Number: 8010042-2021-02167
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2021
• 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?: Yes
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1