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 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the ventilator's support arm was broken.Identification of issue has been done by analyzing problem description and service report.Based on technician statement, the support arm suddenly broke down during use.The support arm was found defective and it was pointed for replacement.The client has contacted a third-part maintenance company to replace the support arm and solve the problem.Since service work was performed by third part company, no details regarding which part of support arm has been broken was obtained.The issue was decided to be reported as broken/damaged support arm may lead to to stop of ventilation (extubation) or injury.In order to conduct further analysis of the case, more detailed information is required.Unfortunately, neither photo of damage nor the claimed part was available for further analyze.Therefore, the root cause to the reported issue has not been determined.

Event Description

It was reported that the ventilator's support arm was broken.There was no patient harm.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: 17735569
• MDR Text Key: 323267882
• Report Number: 8010042-2023-01767
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• 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
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1