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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 ROVER ULTRA (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
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STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 ROVER ULTRA (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 0702001000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2015
Event Type  malfunction  
Event Description
It was reported that at the user facility the device was spitting blood.There was no patient involvement, no surgical delay, no medical intervention, and no adverse consequences.The user facility was not able to provide any further information regarding the reported event.
 
Manufacturer Narrative
After the field service technician finished the device evaluation, it was returned to service at the user facility.
 
Event Description
It was reported that at the user facility the device was spitting blood.There was no patient involvement, no surgical delay, no medical intervention, and no adverse consequences.The user facility was not able to provide any further information regarding the reported event.
 
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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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5290805
MDR Text Key33318813
Report Number0001811755-2015-04522
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2015
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0702001000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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