MAUDE Adverse Event Report: CAREFUSION 3100B; VENTILATOR, HIGH FREQUENCY

Model Number 3100B

Device Problems Decrease in Pressure (1490); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2015

Event Type  Injury  

Manufacturer Narrative

Carefusion complaint number (b)(4).In the event that carefusion receives the device for evaluation or additional information is received a follow-up report will be submitted.(b)(4).At this time, carefusion has not received the device from the customer.

Event Description

On (b)(6) carefusion received a user facility medwatch report (b)(4) that stated "oscillator was in use on the patient and had been for many days.On this day, the patient began to have desaturations so the machine was checked and low pressures were found.After trouble shooting, the machine would still not hold pressure.It was removed and replaced.".

• Brand Name: 3100B
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5165871
• MDR Text Key: 28859691
• Report Number: 2021710-2015-01956
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2015
• Initial Date FDA Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS, LONG-TERM ANTIBIOTICS
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 17 YR
• Patient Weight: 44