MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER NEPTUNE ROVER 3; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number NEPTUNE 3

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

Stryker neptune rover 3 device.Ac (alternating current) power board, f2 fuse.F2 is rated for 20a 250v while the fuse holder itself is rated at 16a 250v; unsure what overcurrent issue is causing f2 to blow, but f2 bubbles and seals fuse holder.This causes extraction of the fuse itself impossible and requires a whole board replacement.This is the 4th rover 3 to undergo this problem out of our fleet of 12 in the timespan of a year.Reference reports: mw5152121, mw5152122, mw5152123.

• Brand Name: STRYKER NEPTUNE ROVER 3
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 18807181
• MDR Text Key: 336765639
• Report Number: MW5152124
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEPTUNE 3
• Device Catalogue Number: 9100-004-746
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other