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

Catalog Number	0702001000
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/20/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
No alleged device malfunction.
Event or Problem Description
It was reported by the customer that during an open abdomen procedure, a patient experienced cardiopulmonary arrest.Per the customer, at the time, the neptune was used as a "wound vac" (vacuum assisted closure) in the procedure, the patient no longer showed vital signs.The customer further reported that a customer employee attempted to use the neptune device to create a "wound vac" to the area where bleeding was profuse.The patient was reported to have died during the procedure.Per the original reporter from the customer, the neptune in no way caused or contributed to the demise of the patient.While it was reported that the neptune did not cause or contribute to the patient¿s condition per the original reporter, using the neptune in conjunction with closed wound drains is a contraindication or usage and could result in a serious injury.

• Brand Name: NEPTUNE 2 ROVER ULTRA (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: 8185131
• Report Number: 0001811755-2018-02860
• Device Sequence Number: 13818018
• Product Code: JCX
• UDI-Device Identifier: 07613154522309
• UDI-Public: 07613154522309
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0702001000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death