MAUDE Adverse Event Report: CAREFUSION, INC 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Should any additional information be received by the customer then an additional report will be submitted.(b)(4).Results of investigation: a carefusion field service representative (fsr) went on site to the reporter's facility and upon evaluation found that the thumbwheel switch was faulty.The fsr replaced the thumbwheel switch and the device passed the patient circuit calibration and performance check, meeting manufacturer specifications for operation.

Event Description

The customer reported that the minimum and maximum mean airway pressure thumbwheel alarms were activating inappropriately on this 3100a high frequency oscillating ventilator.The customer stated that this was detected during the set-up of the device and that there was no patient involvement associated with this reported issue.

Manufacturer Narrative

Device evaluation: the reporter's facility evaluated the involved device.Upon visual inspection there were no apparent disconnections.The customer stated that the patient circuit calibration and the performance checks were "slightly substandard".The issue was resolved after the customer replaced the circuit, indicating a possible previous leak in the system.After the circuit was replaced the device met manufacturer specifications.Carefusion received a medwatch report from the fda submitted by the reporter's facility containing additional information.This report has been updated to reflect the received information and all currently known information regarding this reported issue.

Event Description

The customer reported that this 3100a high frequency oscillating ventilator was being used on a patient when it started giving a low pressure alarm after the patient was repositioned.The alarm condition caused the device to depressurize and the end-user was unable to re-pressurize the system.The device was removed from the patient and alternate ventilation was provided by changing out the unit with a known good unit.The customer stated that there was no patient injury or harm associated with this reported issue.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5698409
• MDR Text Key: 46856276
• Report Number: 2021710-2016-03834
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

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: 3100A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/1999
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 25 DA
• Patient Weight: 1