BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEPWORKS 7.X ACQUISITION SW WITH SPIKE / EVENT AND HIGH RES VIDEO

    MDR report key: 13950160 · Received March 30, 2022

    Report

    Report Number
    9612330-2022-00017
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 23, 2022
    Report Date
    May 23, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    OLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT #(B)(4). . CUSTOMER UNABLE TO PROVIDE ANY IDENTIFYING INFORMATION ON DEVICE. UNABLE TO LOOK ASSET UP. INSTRUCTED CUSTOMER WHERE HE CAN FIND THE INFORMATION ON THE CAMERA. CUSTOMER WILL CALL BACK WHEN HE HAS THAT INFORMATION. UNABLE TO REMOTE INTO SLEEP SYSTEM. CUSTOMER STATED THAT IS LOCKED DOWN, HE IS ALSO NOT NEAR THE SLEEP LAB. 24-MAR-2022: QUESTIONNAIRE SENT TO THE CUSTOMER. 28-MAR-2022: SECOND FOLLOW UP MADE. NO RESPONSE FROM CUSTOMER. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 (REF TO NATUS COMPLAINT# (B)(4)). IT WAS REQUESTED THAT THE DEVICE BE RETURNED FOR EVALUATION. THE CAMERA IS AT LEAST 12 YEARS OLD AND WAS DISCARDED BY THE CUSTOMER WHEN THEY WERE ADVISED THERE WERE NO REPAIR POSSIBILITIES FOR IT. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. 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. PER (B)(4) HAZARD ID LINE 5.22, SEVERITY 3-MARGINAL, RISK LEVEL 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. A DEVICE HISTORY REVIEW IS NOT APPLICABLE BECAUSE, PRIOR TO THE REPORTED ISSUE THE DEVICE WAS IN SERVICE FOR 2 OR MORE YEARS AND A MANUFACTURING DEFECT IS VERY UNLIKELY. UDI NUMBER: NOT APPLICABLE. FAILLURE CONFIRMED: NO. INVESTIGATION RESULT CODE: NEURO SBU/PRODUCT NOT RETURNED. CLOSURE RATIONALE:COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. LOW RISK OF HARM OR SAFETY, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE. COMPLAINTS WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Description of Event or Problem · 0

    CUSTOMER STATED THERE IS AN ISSUE WITH ONE OF THE SLEEP CAMERAS "OVER HEATING" AND NOT RESPONDING TO THE CAMERA CONTROLS (MOVES AROUND IN CIRCLES PER CUSTOMER). NO INJURIES REPORTED.

    Description of Event or Problem · 0

    CUSTOMER STATED THERE IS AN ISSUE WITH ONE OF THE SLEEP CAMERAS "OVER HEATING" AND NOT RESPONDING TO THE CAMERA CONTROLS (MOVES AROUND IN CIRCLES PER CUSTOMER). NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329140 SLEEPWORKS 7.X ACQUISITION SW WITH SPIKE / EVENT AND HIGH RES VIDEO SLEEPWORKS 7.X ACQUISITION SW WITH SPIKE / EVENT AND HIGH RES VIDEO OLZ NATUS MEDICAL INCORPORATED LC201-7

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown