MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 176; SUPPORT, ARM

Model Number SUPPORT ARM 176

Device Problem Fracture (1260)

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

Event Date 07/12/2023

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

It was reported that the ventilator's support arm was broken.Identification of issue has been done by analyzing problem description and service report.Based on technician statement, the clamp mount was identified as faulty and replaced.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 to stop of ventilation (extubation) or injury.There was no patient harm.The root cause to the reported issue has not been determined.

• Brand Name: SUPPORT ARM 176
• 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: 17457710
• MDR Text Key: 320383375
• Report Number: 8010042-2023-01499
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPPORT ARM 176
• Device Catalogue Number: 6405976
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1