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U.S. Department of Health and Human Services

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

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MAQUET CRITICAL CARE AB SERVO-U; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number SERVO-U
Device Problem Infusion or Flow Problem (2964)
Patient Problem Respiratory Acidosis (2482)
Event Date 12/12/2020
Event Type  Injury  
Event Description
It was reported that during patient treatment, the ventilator delivered lower minute volume than set.The patient¿s ph level decreased to 6.9.The ventilator was replaced and the patient recovered from the low ph rapidly.Final patient outcome was no injury.Manufacturer¿s ref #: (b)(4).
 
Manufacturer Narrative
The ventilator was investigated by our field service engineer.The patient circuit and expiratory cassette used during the event was not available.Tests was performed with new patient circuit and expiratory cassette.No fault was found and the ventilator passed pre-use check.No parts were replaced.The ventilator was then returned to clinical use.Provided ventilator logs were reviewed.The logs indicate alarms for leakage in the patient breathing circuit or a disconnect situation; expiratory minute volume and peep low.Successful pre-use check was performed prior and after the event date.The technical log does not contain any technical error codes to indicate that there was a ventilator malfunction at the time of the event.There is no indication of ventilator malfunction at the time of event.The cause of the alarms has not been determined but they were most probably due to leakage.
 
Event Description
Manufacturer's ref#: (b)(4).
 
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Brand Name
SERVO-U
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
MDR Report Key11155380
MDR Text Key226284799
Report Number3013876692-2021-00001
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSERVO-U
Device Catalogue Number6694800
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2021
Distributor Facility Aware Date09/24/2021
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer09/27/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/12/2021
Supplement Dates Manufacturer Received09/24/2021
Supplement Dates FDA Received09/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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