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

Model Number 3100A - UPGRADE

Device Problems Increase in Pressure (1491); Failure to Calibrate (2440)

Patient Problem No Information (3190)

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion complaint #: (b)(4).Customer has been contacted for additional information but has not responded at this time.If additional information is received from the customer, a follow up will be submitted.(b)(4).At this time, it is unknown if the device is available for return and evaluation.Carefusion has not received the suspect device.

Event Description

Customer called to report that the vent won't zero.The lowest he can get is 3.3.He doesn't see any moisture in the pressure transducer so he thinks it is the alarm board.The customer has not stated if there was any patient involvement or patient harm, it is unknown at this time.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• 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: 5207750
• MDR Text Key: 30836397
• Report Number: 2021710-2015-02150
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A - UPGRADE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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