MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 DOCKING STATION (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number	0702014000
Medical Device Problem Codes	Sparking (2595); Electrical Shorting (2926)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the service inspection, it is likely fluid was spilled onto the plug of the device where it mates with the wall outlet, causing the event.
Event or Problem Description
It was reported that during docking the device after a surgical procedure the device short circuited and sparked.No medical intervention and no adverse consequences were reported with this event.As this event occurred after a surgical procedure, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: NEPTUNE 2 DOCKING STATION (120V)
• Common Device Name: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9553093
• Report Number: 0001811755-2020-00012
• Device Sequence Number: 3096306
• Product Code: JCX
• UDI-Device Identifier: 07613154559053
• UDI-Public: 07613154559053
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K132671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

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
• Operator of Device: No Information
• Device Catalogue Number: 0702014000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1