BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIBAND, REGULAR, PKG INSTRUCTION

    MDR report key: 17113999 · Received June 12, 2023

    Report

    Report Number
    9612330-2023-00012
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 17, 2023
    Report Date
    June 22, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    HOY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). THE AFFECTED PART WILL NOT BE RETURNED FOR EVALUATION. THE FAILURE WAS NOT CONFIRMED. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). DISTRIBUTOR PARTNER HAS REPORTED BILIBAND REGULAR, LOT# F07210427R WILL NOT BE RETURNED. ACCEPTABLE RISK AS PER HAZARD ID 13.3 , SEVERITY - 3 IN DOC-039096 BILIBAND EYE PROTECTOR- RISK ANALYSIS SPREADSHEET, RISK IS LOW. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. THERE ARE NO CAPA'S RELATED TO THIS ISSUE AND THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. PER (B)(4) COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. CERTIFICATE OF ANALYSIS WAS REVIEWED, DEVICE ASSESSMENT TESTS HAVE PASS RESULTS. NO ISSUES NOTED. DEVICE HISTORY RECORD HAS BEEN REQUESTED AND WILL BE REVIEWED. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    PART 900642 BILIBAND, REGULAR, PKG INSTRUCTION. BILIBAND SLIPPING OFF PATIENT. THE BABY WAS RECEIVING PHOTOTHERAPY. DISTRIBUTOR PARTNER REPORTED THEIR CUSTOMER REPORTED PHOTOTHERAPY EYE SHIELDS COVERING NOSE OF BABY LEADING TO DESAT TO 85%. EYE SHIELDS DO NOT STAY ON WELL. THEY MOVE EASILY ESPECIALLY WITH WIGGLY BABY. NO INJURY.

    Description of Event or Problem · 0

    PART 900642 BILIBAND, REGULAR, PKG INSTRUCTION. BILIBAND SLIPPING OFF PATIENT. THE BABY WAS RECEIVING PHOTOTHERAPY. DISTRIBUTOR PARTNER REPORTED THEIR CUSTOMER REPORTED PHOTOTHERAPY EYE SHIELDS COVERING NOSE OF BABY LEADING TO DESAT TO 85%. EYE SHIELDS DO NOT STAY ON WELL. THEY MOVE EASILY ESPECIALLY WITH WIGGLY BABY. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252293 BILIBAND, REGULAR, PKG INSTRUCTION BILIBAND, REGULAR, PKG INSTRUCTION HOY NATUS MEDICAL INCORPORATED 900642 F07210427R

    Patients

    Seq Age Sex Outcome Treatment
    1 2 WK Male