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 07/17/2023

Event Type  malfunction  

Event Description

It was reported that the ventilator's support arm used for holding the patient circuit broke.There was no patient harm.Manufacturer's ref #: (b)(4).

Event Description

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

Manufacturer Narrative

It was reported that the ventilator's support arm used for holding the patient circuit broke.The ventilator was investigated on site by our field service engineer and issue was resolved by replacing the support arm clamp.No patient harmed.However, no part returned for investigation.Therefore, no root cause can be established.There was no patient harm.Pre-use check failure also reported due to leak in the expiratory cassette.Issue resolved by cleaning the expiratory cassette membrane.The most probable root cause to the reported issue was that there was dirt on the expiratory cassette membrane.It is very important that the valve membrane and the membrane seat in the expiratory cassette are clean.If there is dirt particles on the valve membrane it may not seal to membrane seat correctly.Dirt particles can create leakage in the expiratory cassette.

• 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: 17423609
• MDR Text Key: 320039113
• Report Number: 8010042-2023-01460
• 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,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1