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

Model Number VMAX ENCORE 22

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If more information becomes available a follow up will be submitted.(b)(4).The carefusion field service engineer (fse) was onsite and stated the arm was tight so when the customer adjusted the arm, it probably put pressure and loosened the screw.The fse tightened the arm and lubricated the joints which solved the reported issue.The fse repaired the impulse oscillatory spirometry (ios) arm and was returned to the customer.The device is currently working without issue.

Event Description

The customer reported the impulse oscillatory spirometry (ios) arm fell off.There was no patient involvement associated with this event.The carefusion field service engineer (fse) was scheduled to inspect the unit at the customer's facility.

• Brand Name: STATIC AND DYNAMIC COMPLIANCE
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 8473628056
• MDR Report Key: 5527757
• MDR Text Key: 41419862
• Report Number: 2021710-2016-03378
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VMAX ENCORE 22
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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