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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
Catalog Number 6694800
Device Problem Material Discolored (1170)
Patient Problems Bradycardia (1751); Vomiting (2144)
Event Date 01/16/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that while the ventilator was connected to a patient, the patient began throwing up, was bradycardic and the breathing pattern became irregular. In an attempt to troubleshoot any mechanical problems, the ng tube for nava (neurally adjusted ventilatory assist) was removed from the patient. It was observed that the end of the ng tube for nava was black and the aspirate obtained before its removal had black flecks in it. The ng tube for nava had been in the patient for 4 days. Enteral feeds through the ng tube for nava were at 8ml of breast milk with no additives and no oral medicines passing through. There was no reported patient harm. (b)(4).

 
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Brand NameSERVO-U
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW
Manufacturer (Section G)
MAGNUS LINDQVIST
maquet critical care ab
röntgenvägen 2, se-171 54
solna
SW
Manufacturer Contact
maquet critical care ab
röntgenvägen 2, se-171 54
solna 
MDR Report Key8316599
MDR Text Key136016449
Report Number8010042-2019-00073
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
PMA/PMN NumberK151814
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,Followup
Report Date 10/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/07/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6694800
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age yr
Event Location No Information
Date Manufacturer Received01/17/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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