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 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is based on picture received.According to the picture, the support arm broke at the joint nearest to the bracket.The support arm is a casting and it most probably developed a crack at an earlier occasion either by overloading or impact and this led to the reported breaking.The support arm has been successfully tested for mechanical strength and is designed according to standard.It is unknown under which circumstances the support arm broke.

Event Description

It was reported that the ventilator¿s support arm holding the patient tubes broke.Patient involvement is unknown.(b)(4).

• 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: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11846999
• MDR Text Key: 251417388
• Report Number: 8010042-2021-01116
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 6487800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1