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

Catalog Number P57820

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

While prepping room for a cervical discectomy with fusion, staff tested equipment, neptune gave a suction error message and stopped working.Patient not in care area at time, no harm to patient.Machine swapped out, no further incident with new equipment.

• Brand Name: NEPTUNE
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 17710768
• MDR Text Key: 322954169
• Report Number: 17710768
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: P57820
• 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: 08/15/2023
• Date Report to Manufacturer: 09/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA