MAUDE Adverse Event Report: CAREFUSION CAREFUSION; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number VMAX MODEL 29C E

Device Problems Electrical /Electronic Property Problem (1198); Grounding Malfunction (1271); Environmental Compatibility Problem (2929); Power Problem (3010)

Patient Problems Dizziness (2194); Thromboembolism (2654)

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up call with the reporter determined that she had her facilities team confirm that there were no electrical faults within the wall sockets she had used.A cfn field service representative was dispatched to assess the situation and he confirmed the presence of discoloration on the prongs of the ac power cord.He replaced the power cord and the isolation transformer as a precautionary measure and tested the system.The vmax system functioned as intended after the transformer and cord replacement.The isolation transformer and the power cord were returned to cfn for evaluation.Discoloration was observed on the prongs of the cord as previously confirmed.A visual examination of the isolation transformer revealed signs of physical damage to the outer case.Internally two sets of connectors were found to be unplugged.There were no signs of internal discoloration or other physical damage noted.Testing of the power cord revealed no further anomalies and the transformer was powered up with the returned power cord and tested under full load conditions with no evidence of overheating or malfunction.

Event Description

It was reported to the carefusion technical support representative by the clinician at the user facility that they came in to find that the vmax system had been moved with the power off.They usually do not power the system off.She then stated "the plug in the wall from the cart was plugged in and she noticed it was sparking, she unplugged it and it sparked again." she then moved it to another outlet and that sparked too when she plugged it in.

• Brand Name: CAREFUSION
• 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 ; 8473628056
• MDR Report Key: 4936863
• MDR Text Key: 22581820
• Report Number: 2021710-2015-01253
• 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: Health Professional
• Report Date: 06/24/2015

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: VMAX MODEL 29C E
• Device Catalogue Number: 777409-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2007
• 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