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

Model Number 3100A

Device Problem Air Leak (1008)

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

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion complaint number: (b)(4).The field service representative evaluated the unit and was able to reproduce the reported event and isolated it to a leak in the cooling gas regulator manifold.The field service representative replaced the regulator manifold assembly which resolved the issue and performed testing before placing the unit back in service.A return material authorization was generated for the return of the regulator manifold however carefusion has yet to receive the sample for evaluation.Upon receipt of the sample or upon receipt of additional information a follow-up report will be submitted.The customer did not provide information if this event occured on a patient.Carefusion has reached out to the customer but has not received a response.At this time carefusion has not received the sample for evaluation.(b)(4).

Event Description

The customer stated: this unit is making an air leaking type noise coming from where the cooling gas is behind the driver.The unit seems to be functioning fine otherwise.

Manufacturer Narrative

Device evaluation: results of investigation: the failure analysis lab received the suspect faulty regulator and was able to reproduce the reported issue and isolated it to a leak in the manifold at pressure regulator number 5.

• 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: 5173670
• MDR Text Key: 29410000
• Report Number: 2021710-2015-02007
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2015
• Initial Date FDA Received: 10/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• 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