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 09/26/2022

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 is damaged.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 returned pictures shows that the support arm broke at the rail clamp.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.There is no information if the support arm has been manufactured before of after implemented changes.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 root cause has been most likely 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: 15517998
• MDR Text Key: 304801477
• Report Number: 8010042-2022-01698
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1