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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 01/22/2021
Event Type  Malfunction  
Event Description

It was reported that the user interface fell off. 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 Key11371204
MDR Text Key233245538
Report Number8010042-2021-00468
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/24/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/24/2021
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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