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 Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Electric Shock (2554)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the user facility a user of the device received an electric shock after the off loading process.No medical intervention and no adverse consequences were reported with this event.As this event occurred after a procedure during off loading of the device, there was no patient involvement and no delay to a surgical procedure.There were no adverse consequences or medical intervention required for the user of the device.

• 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: 7544769
• Report Number: 0001811755-2018-01013
• Device Sequence Number: 16194296
• Product Code: JCX
• UDI-Device Identifier: 07613154559053
• UDI-Public: 07613154559053
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

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: Other
• Device Catalogue Number: 0702014000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1