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

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.

• 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 Key: 7259357
• MDR Text Key: 99820546
• Report Number: 2936999-2018-00078
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• PMA/PMN Number: K021090
• Number of Events Reported: 1
• 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

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NELL3-S
• Device Catalogue Number: NELL3-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Date Manufacturer Received: 09/22/2017
• 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 Number: 1