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

Model Number 3100A

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

The customer reported that while in patient use the glue is separating from the wire in the heated wire circuit and is leaking down into the circuit.No patient compromise; the ventilator is still working properly.

Manufacturer Narrative

Circuit catalog number: 773996.The carefusion failure analysis technician will evaluate the circuit if it is returned to the manufacturer on the return goods authorization.(b)(4).

Manufacturer Narrative

The carefusion failure analysis technician examined quantity (3), unused, 3100a patient circuits p/n: 773996, lot: 0000756822 and found no problems.Removed and closely examined the heater wire from one of the returned patient circuits and could find no issues.The customer¿s complaint that glue is separating from the heater wire could not be duplicated.To determine what caused the problem depicted in the customer¿s photo, the original patent circuit would need to be delivered to the failure analysis lab.Finding/root-cause: could not duplicate, glue is separating from the heater wire, complaint allegation.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• 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: 4877729
• MDR Text Key: 19498832
• Report Number: 2021710-2015-01153
• 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,user facility
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 05/28/2015

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: 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: 05/28/2015
• Initial Date FDA Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1