MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 178; SUPPORT, ARM

Model Number	SUPPORT ARM 178
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the support arm fell off.There was no patient harm.Manufacturer's ref #: (b)(4).
Additional Manufacturer Narrative
Based on technician statement, the there is no information how the breakage occurred.According to the provided photo, the support arm broke on the locking joint.The whole support arm has been replaced to resolve the issue.The device was delivered to the user in working condition.Broken/damaged support arm may lead to stop of ventilation (extubation) or injury.According to installation instructions for support arm 178 (rev.01), the maximum load of the arm is in range between 1 to 3 kg depends on the angle of use of the accessories.It remains unknown if the support arm has been overloaded.The root cause of the issue could not be determined.

• Brand Name: SUPPORT ARM 178
• Common Device Name: 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: 19404534
• Report Number: 8010042-2024-00865
• Device Sequence Number: 6946273
• Product Code: IOY
• UDI-Device Identifier: 07325710000663
• UDI-Public: (01)07325710000663
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SUPPORT ARM 178
• Device Catalogue Number: 6693715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown