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 12/06/2022

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

It was claimed that the support arm holding the patient circuit broke.Identification of issue has been done by analyzing problem description and information provided from field service engineer (fse).There was no patient harm.Based on technician statement, during preventive maintenance visit the support arm was not broken.The accessories was missing from the ventilator.The part must be purchased to resolve the issue.The complaint was decided to be reported based on available information (no information about why support arm needs to be replaced), as the initial description might have underlying causes which represent a reportable event.In the further process of complaint handling the issue was related to missing support arm.This issue will not affect ongoing ventilation.It remains unknow why the part was missing.The root cause to the reported issue has not been determined.

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: 16079353
• MDR Text Key: 306499989
• Report Number: 8010042-2022-02352
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• 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: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1