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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 DOCKING STATION (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
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STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 DOCKING STATION (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 0702014000
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2018
Event Type  malfunction  
Event Description
It was reported that a neptune docker's hose was leaking at the user facility prior to the start of a surgical procedure.Two surgical cases were canceled as a result of the reported event.No medical intervention and no adverse consequences were reported in regards to the event.All cases that were canceled were rescheduled with no impact to the patient.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that a neptune docker's hose was leaking at the user facility prior to the start of a surgical procedure.Two surgical cases were canceled as a result of the reported event.No medical intervention and no adverse consequences were reported in regards to the event.All cases that were canceled were rescheduled with no impact to the patient.
 
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Brand Name
NEPTUNE 2 DOCKING STATION (120V)
Type of Device
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7838307
MDR Text Key119030849
Report Number0001811755-2018-01633
Device Sequence Number1
Product Code JCX
UDI-Device Identifier07613154559053
UDI-Public07613154559053
Combination Product (y/n)N
PMA/PMN Number
K132671
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0702014000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2018
Date Manufacturer Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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