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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER
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MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER Back to Search Results
Catalog Number 70-6529-R
Medical Device Problem Codes Electrical Shorting (2926); Noise, Audible (3273)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/07/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analyzer was returned for evaluation.Reportable event was associated with power on of the analyzer, and resulted in sizzling / crackling electrical sounds.The returned a/c adapter had a damaged connector which was confirmed to be the source of the problem.This specific event was replicated at magellan.No indication of injury or harm to the user or patient.The unit cannot generate results when it loses power.(b)(4).
 
Event or Problem Description
Instrument loses power.Crackling sound heard when a/c adapter is wiggled.
 
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Brand Name
LEADCARE II ANALYZER
Common Device Name
LEADCARE II
Manufacturer (Section D)
MAGELLAN DIAGNOSTICS
101 billerica ave bldg 4
n. billerica MA 01862 1271
MDR Report Key7346355
Report Number1218996-2018-00005
Device Sequence Number39405
Product Code DOF
UDI-Device Identifier00850355006178
UDI-Public00850355006178
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K052549
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 03/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Nurse
Device Catalogue Number70-6529-R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2016
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/07/2016
Initial Report FDA Received Date03/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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