MAUDE Adverse Event Report: CAREFUSION VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number 29C E

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2014

Event Type  malfunction  

Manufacturer Narrative

The carefusion identification file is (b)(4).This is being submitted in response to a two year retrospective complaint review that was performed by carefusion to identify following the issuance of a 483.The carefusion failure analysis lab determined that the returned device powered-up without issue, but the smell of smoke was noted.This was most likely due to a possible short circuit or burned component.Should additional information become available a supplemental report will be submitted.Carefusion continues to track and trend any incident related to this issue.(b)(4).

Event Description

The carefusion field service representative reported that during the install of the vmax encore module, rattling was noted.Once the device was powered-up, smoke was noted as coming from the device.The device was immediately unplugged and examined.

Manufacturer Narrative

Device evaluation: results of investigation: the pwb assy analyzer ctrl bd untested was visually examined.Visual examination of the analyzer board, as received, confirmed the board burned due to a short circuit.The short circuit was caused by the nut that secures the board to the unit since the insulating washer that goes between the nut and the board was missing.

• Brand Name: VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
• 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 ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5428895
• MDR Text Key: 38228524
• Report Number: 2021710-2016-03153
• Device Sequence Number: 1
• Product Code: BTY
• Combination Product (y/n): N
• PMA/PMN Number: K942211
• 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,Followup
• Report Date: 09/26/2014

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: 29C E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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