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

Catalog Number 0702001000

Device Problem Increase in Suction (1604)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2019

Event Type  malfunction  

Event Description

It was reported by the customer that the neptune increased in suction without being prompted.The procedure was completed successfully with the same device without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: NEPTUNE 2 ROVER ULTRA (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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 8749350
• MDR Text Key: 149674718
• Report Number: 0001811755-2019-02175
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 07613154522309
• UDI-Public: 07613154522309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K1532671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0702001000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2011
• 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