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

Catalog Number 6694800

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2017

Event Type  malfunction  

Event Description

It was reported that while the ventilator was connected to a patient, alarms for high and low o2 concentration were generated.There was no patient harm.(b)(4).

Manufacturer Narrative

The ventilator was investigated by our service engineer(fse).Fse could not duplicate the issue during simulated use testing.And no parts were replaced.Our device log evaluation shows that the cause is attributed to the frequent changes of the parameter settings of o2, by the user.The logs show that the user had been changing the parameters up and down, in very short time intervals.The ventilator system takes some time to adapt to these changes, otherwise alarms will be generated for high or low o2 concentrations, as in this case.Our conclusion is that there was no malfunction of the ventilator system at the time of event.(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: 7155592
• MDR Text Key: 96221655
• Report Number: 8010042-2017-00646
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Date Device Manufactured: 12/20/2016
• 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