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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 01/24/2021
Event Type  Malfunction  
Manufacturer Narrative

Investigation was performed on-site by our field service engineer. The reported failure 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 user interface. A new user interface was mounted. The ventilator then passed all functional and safety tests and was cleared for clinical use. No parts were returned for investigation. The broken flange implies that the user interface has been exposed to high mechanical forces. 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

It was reported that the user interface holder broke. There was no patient involvement. Manufacturer's ref #: (b)(4).

 
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Brand NameSERVO-I
Type of DeviceVENTILATOR, 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
sara soderholm roman
roentgenvagen 2
solna 
MDR Report Key11356988
MDR Text Key233058227
Report Number8010042-2021-00419
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
PMA/PMN NumberK123149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/19/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/22/2021
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/21/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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