Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-U; VENTILATOR, CONTINUOUS, FACILITY USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CRITICAL CARE AB SERVO-U; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number SERVO-U
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/24/2021
Event Type  Death  
Event Description
It was reported that the patient expired while on ventilator.The user facility does not believe that there was any ventilator malfunction, but requests an examination.Manufacturer¿s ref #: (b)(4).
 
Event Description
Manufacturer's ref #: (b)(4).
 
Manufacturer Narrative
The ventilator was investigated by our field service engineer.The ventilator was placed on test lung with no alarms or issues.It passed all safety and functional tests and was cleared for clinical use.Evaluation of received ventilator logs was performed.The logs does not contains any shutdowns or technical error codes.The ventilator successfully passed pre-use check prior start of ventilation.There are no indications of a ventilator malfunction.From the user, there are no allegations of a ventilator malfunction or that the ventilator contributed to the patient¿s death.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SERVO-U
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
MDR Report Key11458422
MDR Text Key239057749
Report Number8010042-2021-00536
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K180098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberSERVO-U
Device Catalogue Number6694800
Was Device Available for Evaluation? No
Date Manufacturer Received03/19/2021
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age59 YR
Patient Weight137
-
-