MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 ROVER ULTRA (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number 0702001000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

It was reported that the neptune 2 rover ultra (120v) had bare wires showing through the insulation of the power cord during repair by a stryker field service technician.There was no patient involvement and no adverse consequences associated with the device.

Event Description

It was reported that the neptune 2 rover ultra (120v) had bare wires showing through the insulation of the power cord during repair by a stryker field service technician.There was no patient involvement and no adverse consequences associated with the device.

Manufacturer Narrative

The field service technician was able to confirm the reported event.He found that the power cord had exposed wires.The root cause was determined to be due to the power cord.The power cord¿s insulation can break down exposing the bare copper wires due to being exposed to rough surfaces, sharp edges, or corners.The device was repaired at the customer site.

• Brand Name: NEPTUNE 2 ROVER ULTRA (120V)
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3790606
• MDR Text Key: 4434961
• Report Number: 0001811755-2014-01612
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0702001000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2010
• 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