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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 Problems Inappropriate/Inadequate Shock/Stimulation (1574); Sparking (2595)
Patient Problem Shock (2072)
Event Date 12/15/2015
Event Type  malfunction  
Event Description
It was reported that during transport of the device at the user facility, the device was emitting sparks from the power cord plug and an employee received a shock while winding the cord.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Event Description
It was reported that during transport of the device at the user facility, the device was emitting sparks from the power cord plug and an employee received a shock while winding the cord.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this 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 Key5358831
MDR Text Key35610446
Report Number0001811755-2016-00042
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2016
Is this an Adverse Event Report? No
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? Yes
Date Manufacturer Received08/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2015
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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