MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-U; VENTILATOR, CONTINUOUS, FACILITY USE

Catalog Number 6694800

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Extubate (2402)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while the ventilator was connected to a patient, the support arm that was attached to it got disengaged from the rail and fell to the floor.The patient was consequently extubated.There was no patient harm.Manufacturer ref #: (b)(4).Importer reference #: (b)(4).

Manufacturer Narrative

The support arm was returned for investigation.One of the ball bearings on the rail clamp was stuck.This has most likely contributed to the disengaging of the support arm from the ventilator carrier.No other anomalies were found on the support arm.The root cause of the stuck ball bearing has not been determined.(b)(4).Ref.Exemption #: e2018003.(b)(4).

Event Description

(b)(4).

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 7735201
• MDR Text Key: 115694402
• Report Number: 8010042-2018-00379
• Device Sequence Number: 0
• Product Code: CBK
• PMA/PMN Number: K151814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6694800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1