MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 176; SUPPORT, ARM

Model Number SUPPORT ARM 176

Device Problem Mechanical Problem (1384)

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

Event Date 01/24/2023

Event Type  malfunction  

Event Description

It was reported that the ventilator had an issue with support arm.No more information was available.There was no patient harm.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

It was claimed that the ventilator's support arm was found defective.Identification of issue has been done by analyzing problem description, service report and communication with field service technician (fse).There was no information about patient involvement.Based on the information collected to date, the provided problem description and information provided by the technician, it has been clarified support arm has been defective.Information about which exact part of the support arm has been defective was not obtained.The customer did not accept quotation, therefore any service repair has been conducted.The issue was decided to be reported as if the support arm will be broken, it may lead to stop of ventilation (extubation) or injury.The root cause to the reported issue has not been determined.The correction of fields #h6 adverse event problem and evaluation code - health effect ¿ impact codes #h8 usage of the device was required.This is based on the internal evaluation.Previous health effect ¿ impact code: no health consequences or impact: 2199.Corrected health effect ¿ impact code: insufficient information: 4648.Previous usage of device: unknown.Corrected usage of device: reuse.

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: 16321294
• MDR Text Key: 309025774
• Report Number: 8010042-2023-00289
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• 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
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1