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 05/02/2023

Event Type  malfunction  

Event Description

It was reported that the ventilator's support arm 177 was broken.There was no patient harm reported.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

It was reported that the ventilator's support arm 177 was broken.Identification of issue has been done by analyzing problem description, service report, communication with field service engineer (fse) and provided picture.Based on technician statement it was concluded that the support arm was broken at the joint nearest the bracket.The support arm has been replaced to resolve the issue.The issue was decided to be reported as the broken/damaged support arm may lead to stop of ventilation (extubating) or injury.There was no patient harm.The root cause to the reported issue has not been determined.The correction of field g4 date received by manufacturer was required.This is based on the internal evaluation.Previous date received by manufacturer: 05/02/2023.Corrected date received by manufacturer: 04/26/2023.

Event Description

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: 16894703
• MDR Text Key: 314818142
• Report Number: 8010042-2023-00892
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1