MAUDE Adverse Event Report: STRYKER INSTRUMENTS NEPTUNE; SURGICAL EXHAUST APPARATUS

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 03/25/2016

Event Type  malfunction  

Event Description

Neptune stopped working.Error code 0.7.

• Brand Name: NEPTUNE
• Type of Device: SURGICAL EXHAUST APPARATUS
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 5567013
• MDR Text Key: 42300525
• Report Number: 5567013
• Device Sequence Number: 1
• Product Code: LYU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR