MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 177; SUPPORT, ARM

Model Number SUPPORT ARM 177

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 01/12/2021

Event Type  malfunction  

Event Description

It was reported that the support arm of the ventilator broke.The patient involvement is unknown.Manufacturer ref.#: (b)(4).

Manufacturer Narrative

No repair was requested and no parts were returned.The support arm was reportedly broken and could not be repaired.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.H3 other text : 4117.

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: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11311229
• MDR Text Key: 231356300
• Report Number: 8010042-2021-00326
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• 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: 02/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2017
• 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