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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE

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MAQUET CRITICAL CARE AB SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number SERVO-U
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

The humidifier holder was not investigated by our field service engineer. The humidifier holder was replaced by the healthcare facility but not returned for investigation. The event was confirmed by provided photo showing the humidifier holder arm broken. The consequence of this kind of mechanical damage is that the humidifier gets detached and, in a worst case scenario, falls off the ventilator carrier and may lead to stop of ventilation (extubation) or injury. There are no reported injuries related to this kind of breakage. The humidifier holder is intended for an active humidifier with or without a water bag, and the holder is specified and verified for a total load of 120 n (12 kg). To break the holder arm, extensive force outside intended use is needed. Our conclusion into this matter is that the humidifier holder most likely has been exposed to a mechanical force greater than it is designed to sustain. There is no ventilator malfunction.

 
Event Description

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

 
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Brand NameSERVO-U
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 Key11435175
MDR Text Key238353587
Report Number8010042-2021-00515
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK180098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/08/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/08/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSERVO-U
Device Catalogue Number6694800
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 Received02/10/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/18/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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