MAUDE Adverse Event Report: VITAL SIGNS ENFLOW CONTROLLER UNIT

Model Number 980121EU

Device Problem Sparking (2595)

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

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device has been received and is awaiting evaluation.A follow-up will be submitted once the evaluation is complete.(b)(4).

Event Description

Customer reported that sparks were seen coming from unit and it will no longer turn on.Customer responded to additional information requested stating that there was smoke and or black soot seen when this issue was noticed.The sparks came from the bottom of the unit.To his knowledge no one was injured.

Manufacturer Narrative

(b)(4).The sample was received and an evaluation including functional testing of the device has been performed by carefusion.The device was identified to have the presence of soot.The source of the soot was determined to have come from the astrodyne power supply.The unit was returned to astrodyne who is the manufacturer of this power supply for a detailed root cause investigation which concluded that the root cause of the failure was most likely due to fluid ingress.Astrodyne noted that the power supply pcb was conformal coated to protect against most conditions in the field and that this is a single failure mode style event.The controller is also enclosed in a (b)(4) rated self-extinguishing plastic.The controller was tested and complied with the latest (b)(4) fire enclosure safety requirements and meets the (b)(4) requirements for water ingress.A device history record (dhr) review was also performed for this lot number and there were no issues identified with the material or manufacturing process that would have contributed to the reported issue.(b)(4).

Manufacturer Narrative

(b)(4).Additions/changes: patient identifier - added (b)(6).Manufacturer name, city and state - changed to (b)(4) facility.Mdr reporting contact name and address - added the site details for (b)(4) facility.Date received by manufacturer - 08/30/2016 (date email received from fda with instructions to correct the site registration number).

• Brand Name: ENFLOW CONTROLLER UNIT
• Type of Device: ENFLOW CONTROLLER
• Manufacturer (Section D): VITAL SIGNS; 75 north fairway drive; totowa NJ 60061
• Manufacturer (Section G): VITAL SIGNS; 20 campus drive; dongguan; totowa NJ 53262 0; CH 532620
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5320744
• MDR Text Key: 34782708
• Report Number: 3010838917-2015-00012
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980121EU
• Device Lot Number: 31031450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2013
• 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