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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JABIL CIRCUIT (SHANGHAI) LTD NELLCOR; OXIMETER

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JABIL CIRCUIT (SHANGHAI) LTD NELLCOR; OXIMETER Back to Search Results
Model Number NELL3-S
Device Problems False Reading From Device Non-Compliance (1228); Low Readings (2460)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/20/2017
Event Type  malfunction  
Manufacturer Narrative
Complete device was not returned for analysis, customer sent the nell3-s board in for testing.Sample was put through mechanical testing and the reported issue was verified.The module generated erratic (high/low) readings during extended testing.The issue was isolated to a defective u19 component.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report the spo2 monitor was generating erratic/low readings between mid 90's to high 20's.There was no patient injury with this event.
 
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Brand Name
NELLCOR
Type of Device
OXIMETER
Manufacturer (Section D)
JABIL CIRCUIT (SHANGHAI) LTD
no 600 tian lin road
shanghai 20023 3
CN  200233
Manufacturer (Section G)
JABIL CIRCUIT (SHANGHAI) LTD
no 600 tian lin road
shanghai 20023 3
CN   200233
Manufacturer Contact
sharon murphy
15 hampshire street
mansfield, MA 02048
2034925267
MDR Report Key7259357
MDR Text Key99820546
Report Number2936999-2018-00078
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
PMA/PMN Number
K021090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/09/2018
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 Model NumberNELL3-S
Device Catalogue NumberNELL3-S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2018
Initial Date Manufacturer Received 09/22/2017
Initial Date FDA Received02/09/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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