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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 06/30/2020
Event Type  malfunction  
Event Description
It was reported that the monitor broke off the stand.There was no patient involvement.(b)(4).
 
Event Description
Manufacturer ref.#: (b)(4).
 
Manufacturer Narrative
The investigation of the user interface holder has been finalized.The device was investigated at the hospital by our field service engineer.The reported failure/defect could be confirmed, and it was found that the flange of the head shaft was broken away.The flange is a part of the fixing mechanism at the bottom of the head shaft for the support hinge to the panel.The broken flange implies that the panel unit has been exposed to high mechanical forces.The consequence too this kind of mechanical damage is that the panel gets detached and in a worst case falls off the ventilator carrier.Our conclusion into this matter is that the panel has been exposed to a mechanical force greater than it¿s designed to sustain.
 
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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 Key10287576
MDR Text Key199292182
Report Number8010042-2020-00444
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 company representative,health
Type of Report Initial,Followup
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
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 Received01/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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