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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 No Known Impact Or Consequence To Patient (2692)
Event Date 02/03/2021
Event Type  malfunction  
Event Description
It was reported that the ventilator's air gas module was defective.There was no patient harm.Manufacturer's ref #: (b)(4).
 
Event Description
Manufacturer's ref #: (b)(4).
 
Manufacturer Narrative
The ventilator was investigated on site, the problem was reproduced and the air gas module was replaced and returned for investigation.Simulated use testing of the returned air gas module could reproduce the described customer issue.No device log files have been received.Our investigation has concluded that the reported problem was caused by a defective pressure transducer on a printed circuit board inside the gas module.The pressure transducer is part of the flow measuring in the gas module.The failure of the pressure transducer leads to inaccurate gas flow regulation which will be detected during pre-use check and alarms will be activated if the failure occurs during ventilation.
 
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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 Key11357107
MDR Text Key232792390
Report Number8010042-2021-00435
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K180098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/17/2021
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 Health Professional
Device Model NumberSERVO-U
Device Catalogue Number6694800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/03/2021
Initial Date FDA Received02/22/2021
Supplement Dates Manufacturer Received03/16/2021
Supplement Dates FDA Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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