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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 Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that the ventilator's user interface holder broke.There was no patient harm.Manufacturer's ref # : (b)(4).
 
Manufacturer Narrative
The ventilator was investigated by our field service engineer (fse).The reported failure was confirmed and the user interface holder was replaced.The ventilator was returned to clinical use.No parts were returned for investigation.The failure was confirmed with a photo provided the fse.The consequence to this kind of mechanical damage is that the user interface gets detached and in a worst case falls off the ventilator carrier.Our conclusion is that the user interface has been exposed to a mechanical force greater than it is designed to sustain.
 
Event Description
Manufacturer's ref #: 270917.
 
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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 Key9382349
MDR Text Key168920102
Report Number8010042-2019-00864
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,foreig
Type of Report Initial,Followup
Report Date 02/18/2020
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-I
Device Catalogue Number6487800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/20/2019
Initial Date FDA Received11/27/2019
Supplement Dates Manufacturer Received11/20/2019
Supplement Dates FDA Received02/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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