MAUDE Adverse Event Report: CAREFUSION STATIC AND DYNAMIC COMPLIANCE; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number 22D E

Device Problems Sparking (2595); Environmental Particulates (2930)

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

Event Date 07/01/2013

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted in response to a two year retrospective complaint review that was performed by carefusion to identify mdrs following the issuance of a 483.The (b)(4) the device was not returned so no investigation could be done and no root cause could be determined.The device is currently working without issue.If more information becomes available a follow up will be submitted.Carefusion continues to track and trend any incident related to this issue.(b)(4).

Event Description

The customer reported the isolation transformer started to spark and smell like smoke as if the system was burning.The system was not used after the reported incident.The customer's biomed took a look at the device and determined that the sparking was coming from the wall outlet and not associated with the pulmonary function testing (pft) system.The customer is now using the device without any issues.There was no harm or injury noted.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• 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 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5429096
• MDR Text Key: 38490362
• Report Number: 2021710-2016-03158
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 07/01/2013

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: 22D E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2013
• Initial Date FDA Received: 02/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1