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

Model Number SERVO-I

Device Problem Fracture (1260)

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

Event Date 07/28/2022

Event Type  malfunction  

Event Description

It was reported that the support arm holding the patient circuit was broken.Patient involvement is unknown.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

It was reported that the support arm holding the patient circuit was broken.Identification of issue has been done by analyzing problem description, service report and communication with field service technician (fse).Investigated complaint was decided to be reported based on available information (no information about which part of support arm was broken), as the initial description might have underlying causes which represent a reportable event.In the further process of complaint handling the issue was related with broken flexible rod.This issue will be noticed during setup and appropriate measures taken.There was no patient harm.The root cause to the reported issue has not been determined.The correction of the field usage of device was required.This is based on the internal evaluation.Previous usage of device: unknown.Corrected usage of device: reuse.

Event Description

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

• Brand Name: SERVO-I
• 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: 15274916
• MDR Text Key: 302336498
• Report Number: 8010042-2022-01460
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K123149
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1