MAUDE Adverse Event Report: VITAL SIGNS ENFLOW CONTROLLER UNIT

Model Number 980121EU

Device Problems Device Emits Odor (1425); Sparking (2595)

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

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint sample has not yet been received for evaluation.A serial number has not been provided.A follow-up mdr will be submitted once the unit has been received and evaluated.

Event Description

It was reported that a spark was observed from where the cable connects to the controller.A burning smell was reported.

Manufacturer Narrative

(b)(4).Multiple attempts have been made by cfn to the customer and the customer has not returned the unit or provided additional information.In the event that this unit is received for evaluation the complaint will be re-opened and a follow-up submission will be sent.

Manufacturer Narrative

(b)(4).Additions/changes: patient identifier - added (b)(6).Manufacturer name, city and state - changed to (b)(4).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 road; totowa NJ
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5226683
• MDR Text Key: 31572014
• Report Number: 3010838917-2015-00011
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980121EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2016
• 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