MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-S; SUPPORT, ARM

Model Number SERVO-S

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

It was reported that the support arm 176 was broken.There was no patient harm reported.Manufacturer's ref.#: (b)(4).

Event Description

Manufacturers ref: # (b)(4).

Manufacturer Narrative

Our field service engineer investigated the ventilator on site and replaced the broken support arm.The device passed all performance and safety tests according to factory specifications and was returned to customer for clinical use.The clamp mount is a part of support arm and is mounted directly to the servo device.The support arm serves to relieve the patient from the weight of the tubing system.The root cause as to why the support arm was broken could not be established by this investigation.

• Brand Name: SERVO-S
• 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: 16909168
• MDR Text Key: 314977280
• Report Number: 8010042-2023-00900
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: MC
• PMA/PMN Number: K123149
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-S
• Device Catalogue Number: 6405976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1