MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 ROVER ULTRA (230V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number	0702002000
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during set up for a procedure, the device's plug melted when plugged into an outlet.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported by the customer that during set up for a procedure, the device's plug melted when plugged into an outlet.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: NEPTUNE 2 ROVER ULTRA (230V)
• 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: 8111782
• Report Number: 0001811755-2018-02572
• Device Sequence Number: 2165303
• Product Code: JCX
• UDI-Device Identifier: 07613154559046
• UDI-Public: 07613154559046
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K132671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: Health Professional
• Device Catalogue Number: 0702002000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1