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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR MAQUET GETINGE SERVO GUARD; FILTER, BACTERIAL, BREATHING-CIRCUIT
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MAQUET CARDIOVASCULAR MAQUET GETINGE SERVO GUARD; FILTER, BACTERIAL, BREATHING-CIRCUIT Back to Search Results
Catalog Number 6595487
Device Problems Device Alarm System (1012); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 01/08/2021
Event Type  malfunction  
Event Description
Called to patient's room by rn due to alarming ventilator presumed to be related to water in ventilator tubing.I noted increased peak inspiratory pressure and drained water from tubing.Flow graphics still demonstrated significant obstruction.Ultimately, i changed the expiratory filter even though it appeared dry.This resolved the problem.The filter was clearly defective, but the source of the flaw is not known.Increased resistance in filter.Condensation not falling into water trap and remaining within filter.
 
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Brand Name
MAQUET GETINGE SERVO GUARD
Type of Device
FILTER, BACTERIAL, BREATHING-CIRCUIT
Manufacturer (Section D)
MAQUET CARDIOVASCULAR
45 barbour pond drive
wayne NJ 07470
MDR Report Key11228726
MDR Text Key228652214
Report Number11228726
Device Sequence Number1
Product Code CAH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/21/2021
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 Lay User/Patient
Device Catalogue Number6595487
Device Lot Number2046
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/21/2021
Event Location Hospital
Date Report to Manufacturer01/26/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age3650 DA
Patient Weight45
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