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

Device Problems Display or Visual Feedback Problem (1184); Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

Error displays and neptune waste management system shut off during case.A different neptune obtained (on standby in room).Case continued without further incident.No harm to patient.Standby neptune in room due to current issues with device, stryker working with user facility to discover/resolve the issue.

• 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: 16654821
• MDR Text Key: 312412080
• Report Number: 16654821
• 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: 03/06/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2023
• Date Report to Manufacturer: 03/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA