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: CAREFUSION SENSORMEDICS HF OSCILLATOR; VENTILATOR, HIGH FREQUENCY
  • 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
 

CAREFUSION SENSORMEDICS HF OSCILLATOR; VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number 3100B
Device Problems Burst Container or Vessel (1074); Decrease in Pressure (1490)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2014
Event Type  malfunction  
Event Description
Staff were at patient's bedside to perform an alveolar recruitment maneuver- while adjusting the bias flow knob, the spring within the knob blew out of the machine causing the oscillator to lose pressure.The respiratory technician was able to hold the knob in place while calling the supervisor, who sent someone up to see if he could help.It was determined that the oscillator would need to be changed out with another machine.Another oscillator was recalibrated and brought up to the patient's room and the patient was then placed on the new machine.The old was taken downstairs to for biomed to repair.Initiall oscillator #403166974 current oscillator that patient is on is 400497675.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SENSORMEDICS HF OSCILLATOR
Type of Device
VENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
CAREFUSION
22745 savi ranch parkway
yorba linda CA 92887
MDR Report Key4459183
MDR Text Key5325476
Report Number4459183
Device Sequence Number1
Product Code LSZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 01/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3100B
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/09/2015
Event Location Hospital
Date Report to Manufacturer01/28/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/09/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age31 YR
-
-