MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 177; SUPPORT, ARM

Model Number SUPPORT ARM 177

Device Problem Fracture (1260)

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

Event Date 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the support arm for patient tubes broke.No repair was requested and no parts were returned.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.Previous investigations of similar faults led to a redesign and change of the manufacturing process in order to obtain a higher mechanical strength of the support arm.The support arm associated with this complaint had been manufactured before this change was implemented in production.Type of investigation: 4117.

Event Description

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

• Brand Name: SUPPORT ARM 177
• 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: 16545568
• MDR Text Key: 311324747
• Report Number: 8010042-2023-00561
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2023

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 177
• Device Catalogue Number: 6481720
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1