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

Catalog Number 6694800

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the humidifier holder was broken.There was no patient involvement.(b)(4).

Event Description

Importer ref.#:(b)(4).Manufacturer ref.#: (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #: (b)(4).Getinge usa sales, llc (b)(4).Contact peron:(b)(6).Our field service engineer (fse) investigated the humidifier holder on site and confirmed the reported event.The humidifier holder was replaced but not returned for investigation.The ventilator and humidifier holder was cleared for clinical use.The failure was confirmed by provided photo showing the humidifier holder arm detached from the plate intended to be inserted into the rail clamp mounted on the ventilator carrier.The consequence of this kind of mechanical damage is that the humidifier gets detached and, in a worst case scenario, falls off the ventilator carrier.The plate is secured in the humidifier holder arm with a securing screw.As a design improvement, an additional securing screw has been introduced.Our conclusion into this matter is that the humidifier holder most likely has been exposed to a mechanical force greater than it is designed to sustain.

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 8358417
• MDR Text Key: 137129598
• Report Number: 8010042-2019-00108
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K151814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 6694800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 11/30/2018
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1