MAUDE Adverse Event Report: STRYKER CORPORATION STRYKER NEPTUNE 3 ROVER; APPARATUS, SUCTION, AND EXHAUST

Model Number 0703001000

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 04/08/2019

Event Type  malfunction  

Event Description

Around 1450 a staff member called the charge nurse regarding the surgeon's concern of a smoke smell from the or room.I went in the room and smelled smoke from the right bottom corner of the room coming from the hallway.I informed the charge nurse and instructed her to activate a fire code.Patient was draped but no incision was made yet.The back table, mayo stand and patient's covered with drape.The surgeon told me that the odor that it was coming from the trashbag.I took the trashbag from the room and opened it but did not smell anything.I also took the hovermat machine outside the room and did not smell anything from it either.Another team member walked in and figured that the neptune machine was creating the smoke smell.The machine was unplugged.Fire marshall and fire safety walked in the room and was informed about the neptune machine.Neptune machine given to clinical engineering.Stryker neptune 3 rover ref 0703-001-000; sn (b)(4).Device had passed pm's approximately 2 months ago.

• Brand Name: STRYKER NEPTUNE 3 ROVER
• Type of Device: APPARATUS, SUCTION, AND EXHAUST
• Manufacturer (Section D): STRYKER CORPORATION; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 8539297
• MDR Text Key: 142745950
• Report Number: 8539297
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0703001000
• Device Catalogue Number: 0703-001-0003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA