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

Model Number 3100B

Device Problems Calibration Error (1078); Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer called requesting a service call for this vent that won't pass the patient circuit calibration.No patient involvement.He stated that the factory biomed is no longer working there, but that he ordered a part for this vent before he left.The customer doesn't know when this ventilator "failed".

Manufacturer Narrative

The carefusion field service representative evaluated the unit and determined the root cause to be due to the unit needing a 2,000 hour preventative maintenance, and power driver module calibration.A replacement adjust valve and pressure regulator 2 were needed, and the unit was missing screws/nuts on pressure regulator 2, pressure regulator 3, and pressure regulator 6.

• 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: 5157624
• MDR Text Key: 28747613
• Report Number: 2021710-2015-01915
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• 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?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2009
• 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