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

Catalog Number 0702014000

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/20/2014

Event Type  malfunction  

Event Description

It was reported that during docking at the user facility, the device was leaking, which caused a one hour delay to the procedure.The procedure was completed successfully.No medical intervention was reported with this event.

Event Description

It was reported that during docking at the user facility, the device was leaking, which caused a one hour delay to the procedure.The procedure was completed successfully.No medical intervention was reported with this event.

Manufacturer Narrative

No failure was detected in the device, however, the detergent bottle connected to the device was found to be damaged and leaking.The device was serviced for preventive maintenance at the user facility and returned to service.

• Brand Name: NEPTUNE 2 DOCKING STATION (120V)
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4255036
• MDR Text Key: 5017600
• Report Number: 0001811755-2014-04136
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2014

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 Catalogue Number: 0702014000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 11/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1