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 11/29/2022

Event Type  malfunction  

Event Description

It was reported that the support arm holding the patient circuit broke.Patient involvement is unknown.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

It was claimed that support arm needs to be replaced.The device failed to meet its specifications, it is unknown if it has been used at the time of the event.There have been no adverse event sustained as a result of the issue.The evaluation of the provided information revealed that whole arm has been damaged.The support arm is cast and has most likely previously cracked at an earlier occasion either by overloading or impact, the crack widened and this led to the reported breakage.Previous investigations led to a redesign and a change of the manufacturing process in order to obtain a higher mechanical strength of the support arm.This change was implemented in production during september 2009.According to information provided by the technician, a grey color of cover on support arm's joint revealed that the part has been manufactured after design implementation.In the installation manual for the support arm 176 in the specification of the maximum capacity, it is stated how many kilograms can be loaded depending on the angle of use of the accessories (max.Approx.3 kg).The most likely root cause is related to usability.

Event Description

Manufacturer's ref #: (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: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 16136588
• MDR Text Key: 307073885
• Report Number: 8010042-2023-00072
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/11/2023

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 176
• Device Catalogue Number: 6405976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1