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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 Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 01/21/2021
Event Type  malfunction  
Event Description
It was reported that the ventilator was experiencing an issue.Detailed description of the event is not available at this point.The patient involvement is unknown.Manufacturer ref.#: (b)(4).
 
Event Description
Manufacturer's ref.#: (b)(4).
 
Manufacturer Narrative
The ventilator was investigated at site by our field service engineer.The nozzle unit in the gas modules and moisture trap and inspiratory pipe were found defective.After replacement, the ventilator passed all functional and safety tests and was cleared for clinical use.The nozzle unit is part of the gas module and regulates the inspiratory gas flow to the patient.It consists of a membrane, a mouthpiece and a feather spring.The membrane in the nozzle unit is pressed against a mouthpiece with a feather spring to regulate the gas flow through the gas module.No device logs were received and no replaced parts were returned for investigation, therefor the root cause for the reported problem could not be determined.
 
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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 Key11347688
MDR Text Key232514375
Report Number8010042-2021-00426
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 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
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
Date Manufacturer Received10/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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