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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO EVAC 180
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MAQUET CRITICAL CARE AB SERVO EVAC 180 Back to Search Results
Catalog Number 9151465
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/26/2015
Event Type  malfunction  
Event Description
It was reported that while the ventilator was connected to a pt the attached open gas evacuation sys's bag became very big and it couldn't release the gas.The ventilator and the open gas evacuation sys were replaced.(b)(4).
 
Manufacturer Narrative
Our field svc engineer who was dispatched to the hosp examined both the ventilator and the gas evacuation sys.The fse found both of them functioning normally.No parts were replaced and both were returned to svc.The cause of the reported experienced difficulty has not been determined.
 
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Brand Name
SERVO EVAC 180
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW 
Manufacturer Contact
magnus lindgvist
2 roentgenvagen
solna S-171-54
SW   S-17154
7307705
MDR Report Key4552948
MDR Text Key18889047
Report Number8010042-2015-00078
Device Sequence Number1
Product Code CBN
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K852772
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/27/2015
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 Number9151465
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2015
Initial Date FDA Received02/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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