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

Model Number SUPPORT ARM 179

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Provided picture showed that the metal fastening mechanism on the rail clamp mounted on the support arm had fallen off.The support arm will be replaced.The root cause of the reported issue has not been determined.

Event Description

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

Event Description

Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The support arm was returned for investigation.The fixation plate on the rail clamp that is used for fixating the support arm on the ventilator¿s side rail was missing and the fixation screw was broken 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.

• 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: 10301814
• MDR Text Key: 199685283
• Report Number: 8010042-2020-00457
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose