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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 Suction Problem (2170)
Patient Problem Low Oxygen Saturation (2477)
Event Date 09/19/2023
Event Type  Injury  
Event Description
It was reported that during routine patient suctioning, a vacuum inside the patient circuit was caused which fully collapsed sections of the expiratory tube.The expiratory tube was disconnected and reconnected, relieving the vacuum.The ventilator was then functioning correctly, and patient treatment could continue.The patient had a desaturation to an spo2 level of 29% before recovering fully to normal spo2 level.Final patient outcome was no harm.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
Manufacturer (Section G)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
Manufacturer Contact
caroline kabbabe
roentgenvagen 2
solna 
MDR Report Key18333775
MDR Text Key330546618
Report Number8010042-2023-02466
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K201874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2023
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
Date Manufacturer Received12/07/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/08/2020
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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