MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 179; SUPPORT, ARM

Model Number SUPPORT ARM 179

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

No repair was requested and no parts were returned.Pictures were provided showing the fixation plate on the rail clamp that is used for fixating the support arm on the ventilator¿s side rail had fallen off.The root cause of the broken support arm has not been conclusively determined but most likely has it been exposed to a mechanical force greater than it is designed to sustain.

Event Description

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

• Brand Name: SUPPORT ARM 179
• 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: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 13024042
• MDR Text Key: 282384254
• Report Number: 8010042-2021-02979
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPPORT ARM 179
• Device Catalogue Number: 6882001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose