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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 Circuit Failure (1089)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2019
Event Type  malfunction  
Event Description
It was reported by the customer that during set up for a procedure, the device's plug was found charred.Back-up equipment was used to complete the procedure.No clinically significant delay, no adverse consequences and no medical intervention were reported.
 
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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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key8793741
MDR Text Key151134386
Report Number0001811755-2019-02286
Device Sequence Number1
Product Code JCX
UDI-Device Identifier07613154522309
UDI-Public07613154522309
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132671
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/16/2019
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
Device Operator Health Professional
Device Catalogue Number0702001000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/20/2019
Initial Date FDA Received07/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2015
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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