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 08/15/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Per user facility medwatch report: (b)(4).The patient was placed on the oscillator, however two days later the patient began to desaturate and was not getting enough oxygen.The patient was sedated and was not moving or breathing over the ventilator.The rt began trouble shooting to see if the problem was water in the tubes, etc.But it did not work.The machine had to be replaced as it would not maintain pressure causing the patient to desaturate and required bmv treatment until the machine could be changed.

• 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: 5165400
• MDR Text Key: 28826792
• Report Number: 2021710-2015-01955
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• 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: Respiratory Therapist
• Device Model Number: 3100B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• 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, DIALYSIS
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 74