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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-I; VENTILATOR, CONTINUOUS, FACILITY USE
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MAQUET CRITICAL CARE AB SERVO-I; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number SERVO-I
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that the ventilator's safety valve was defective.There was no patient harm.(b)(4).
 
Event Description
The user interface was not working.There was no patient involvement.Manufacturer's ref.#: (b)(4).
 
Manufacturer Narrative
The initial information that was received stating a defective safety valve was incorrect.The information received now states that the ventilator was examined and it was found that the user interface (ui) (touchscreen) was not working.The ui has been replaced and the ventilator was put back in service.The ui has not been returned for investigation therefore the true cause of its malfunctioning has not been determined.The user interface is for setting ventilation modes, displaying patient date and indication of alarms.The malfunctioning of the user interface will be noticed before start or it will not affect ongoing ventilation.Ongoing ventilation will continue unabated with the set parameters and alarm limits.The ui does not mix or regulate gases nor does it deliver or exchange gases to the patient.H3 other text : not returned.
 
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Brand Name
SERVO-I
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
MDR Report Key11257180
MDR Text Key229592786
Report Number8010042-2021-00229
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K123149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSERVO-I
Device Catalogue Number6487800
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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