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 07/05/2021

Event Type  malfunction  

Event Description

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

Event Description

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

Manufacturer Narrative

It was reported that the support arm 177 mounted on ventilator - servo-i was broken.The reported issue has been confirmed during evaluation of the provided problem description and service report.Based on information provided, the issue was resolved by replacing support arm 177.The photo of the broken part was not available for further evaluation.The main function of support arm is carrying the patient tubes, which connects the ventilator to the patient.In order to conduct further analysis of the case, more detailed information is required.Unfortunately, the faulty part has not been returned for further analysis as it was discarded.Therefore, the root cause of the failure cannot be established.

• 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: 12195288
• MDR Text Key: 262396572
• Report Number: 8010042-2021-01783
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• 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
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1