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

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 12/27/2022

Event Type  malfunction  

Event Description

A prefill 7.7 "level error" displayed on a neptune waste management system.A back-up machine was in room and put in place, case continued without issue.This is a known problem with the neptune and stryker is working with hospital staff to attempt to resolve the issue.No harm to patient.

• Brand Name: NEPTUNE
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 16654705
• MDR Text Key: 312412104
• Report Number: 16654705
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2023
• Date Report to Manufacturer: 03/31/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA