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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEPHROS NEPHROS; S100
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NEPHROS NEPHROS; S100 Back to Search Results
Model Number S100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 04/29/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation is underway.We are awaiting final investigation results and laboratory results.Upon completion, the information will be reviewed and the finding published.Anticipated completion date: june 07th 2019.
 
Event Description
The investigation is currently underway.The manufacture was informed that the customer experienced a positive legionella result.
 
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Brand Name
NEPHROS
Type of Device
S100
Manufacturer (Section D)
NEPHROS
380 lackawanna place
south orange NJ 07079
Manufacturer Contact
vashone thomas
380 lackawanna place
south orange, NJ 07079
2013450829
MDR Report Key8652580
MDR Text Key146658144
Report Number3003337893-2019-00001
Device Sequence Number1
Product Code NHV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Administrator/Supervisor
Remedial Action Replace
Type of Report Initial
Report Date 05/29/2019
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 Other
Device Expiration Date03/28/2020
Device Model NumberS100
Device Catalogue Number70-0280
Device Lot NumberPI17/0180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/29/2019
Initial Date FDA Received05/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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