BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNOP NEO PT

    MDR report key: 5717605 · Received June 10, 2016

    Report

    Report Number
    2031172-2016-00700
    Event Type
    Malfunction
    Date Received
    June 10, 2016
    Date of Event
    March 19, 2016
    Report Date
    May 19, 2016
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K042536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: THIS FOLLOW-UP MDR IS IN RESPONSE TO AN FDA REQUEST AND IS BEING SUBMITTED TO UPDATE H2 IF FOLLOW-UP, WHAT TYPE?. H2 IF FOLLOW-UP, WHAT TYPE? FIELD WAS BLANK; IS DEVICE EVALUATION. E1. INITIAL REPORTER ZIP CODE EXCEEDED ALLOWABLE FIELD LENGTH, INITIAL REPORTER ZIP CODE IS AS FOLLOWS: (B)(6).

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: MFR REPORT NUMBER CORRECTED FROM 2031172-2016-00688 TO 2031172-2016-00700. A1 PATIENT IDENTIFIER: CORRECTED FROM (B)(6) TO (B)(6). H6 METHOD: CHANGED FROM 10 - ACTUAL DEVICE EVALUATED TO 11 - DEVICE FROM SAME LOT EVALUATED H10 ADDITIONAL NARRATIVE: CORRECTED FROM: THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER THREE (3) YEARS WITH NO PREVIOUS REPORTED ISSUES RELATED TO THIS REPORTED EVENT TO: THE PRODUCT ASSOCIATED WITH THIS COMPLAINT HAS BEEN DISCARDED; A RETAINED SENSOR FROM THE SAME LOT WAS USED FOR TESTING. DURING EVALUATION THE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HOSPITAL'S MEDICAL ENGINEER WAS AT THE MASIMO JAPAN EXHIBITION BOOTH AT BIO MED/CLINICAL ENGINEER ANNUAL CONGRESS. HE RECALLED THE EVENT WAS REPORTED BY THE HEAD NURSE. SUBSEQUENTLY, MASIMO SALES REPRESENTATIVE VISITED THE HOSPITAL AND WAS ABLE TO GATHER INFORMATION REGARDING THE PATIENT EVENT. THE AFFECTED AREA WAS AT THE DORSUM/SOLE OF PATIENT'S FOOT. THE AFFECTED AREA IS DESCRIBED AS "WRINKLY SKIN". DURING THE 24 HOURS OF SENSOR USAGE, THE SENSOR SITE WAS NOT CHECKED. THERE WAS NO MEDICAL INTERVENTION PROVIDED. THE AFFECTED AREA HAS HEALED AND THE PATIENT HAS BEEN DISCHARGED. THE PATIENT IS A NEWBORN, MALE.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. IT WAS INDICATED THAT THE SENSOR USED DURING THE REPORTED EVENT HAS BEEN DISCARDED; THEREFORE, COULD NOT BE RETURNED TO MASIMO FOR EVALUATION. IF NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL'S (B)(6) WAS AT THE MASIMO (B)(4) EXHIBITION BOOTH AT (B)(4). HE RECALLED THE EVENT WAS REPORTED BY THE (B)(6). SUBSEQUENTLY, MASIMO SALES REPRESENTATIVE VISITED THE HOSPITAL AND WAS ABLE TO GATHER INFORMATION REGARDING THE PATIENT EVENT. THE AFFECTED AREA WAS AT THE DORSUM/SOLE OF PATIENT'S FOOT. THE AFFECTED AREA IS DESCRIBED AS "WRINKLY SKIN". DURING THE 24 HOURS OF SENSOR USAGE, THE SENSOR SITE WAS NOT CHECKED. THERE WAS NO MEDICAL INTERVENTION PROVIDED. THE AFFECTED AREA HAS HEALED AND THE PATIENT HAS BEEN DISCHARGED. THE PATIENT IS A (B)(6), MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372989 LNOP NEO PT OXIMETER DQA MASIMO CORPORATION 1003 15MQF

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Male Other