MAUDE Adverse Event Report: STRYKER CORPORATION NEPTUNE; APPARATUS, EXHAUST, SURGICAL

Model Number 0703-001-000

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/09/2020

Event Type  malfunction  

Event Description

Anesthesia.

• Brand Name: NEPTUNE
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 2825 airview boulevard; kalamazoo MI 49002
• MDR Report Key: 10553177
• MDR Text Key: 207515835
• Report Number: 10553177
• Device Sequence Number: 1
• Product Code: FYD
• 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: 08/31/2020

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 Operator: Health Professional
• Device Model Number: 0703-001-000
• 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: 08/31/2020
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1