BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICVIEW

    MDR report key: 14552669 · Received May 31, 2022

    Report

    Report Number
    9612330-2022-00034
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    May 5, 2022
    Report Date
    September 15, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT (REF NATUS COMPLAINT# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED: NO PATIENT INVOLVED AT THE TIME OF THE INCIDENT. NO DEATH OR SERIOUS INJURY THAT REQUIRED MEDICAL TREATMENT. NO DELAY IN TREATMENT. NO ENVIRONMENTAL OR SAFETY CONCERNS. THE SERVICE TECH SET UP TO SHIP A REPLACEMENT ARM (ARM-001), CLAMP (CLAMP-001) AND POWER CORD (A1011X) TO THE CUSTOMER. AFFECTED PRODUCT HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 (REF NATUS COMPLAINT# (B)(4)). QMS-002413 COMPLAINT INVESTIGATION FORM SHOWS THE STAFF MECHANICAL ENGINEER COMPLETED THE INVESTIGATION: INVESTIGATION RESULTS: THE ARM WAS RETURNED IN PIECES AND MOST OF THE PIECES WERE INCLUDED. THE ARM SHOWED SIGNIFICANT DAMAGE INCLUDING CRACKING OF THE PLASTIC AROUND THE MOUNTING PIVOT, CRACKING AT THE POWER SWITCH AND WEAR OF THE METAL SHAFT THAT MOUNTS IN THE CLAMP. THIS ARM HAS DOCUMENTED ISSUES WITH THE PLASTIC CRACKING AROUND THE METAL ARM PIVOT POINT. AS THIS PLASTIC CRACKS IT MAKES THE PIVOT LOOSEN REQUIRING THE SCREW TO BE TIGHTENED TO MAINTAIN THE DESIRED POSITION. THIS CAUSES THE PLASTIC TO CRACK MORE, AND THE SCREW MUST BE TIGHTENED AGAIN. WHEN THE CRACKING BEGINS AND IS VISIBLE THE ARM SHOULD BE CONSIDERED DAMAGED BY THE CUSTOMER AND TAKEN OUT OF SERVICE. THIS ARM WAS NOT TAKEN OUT OF SERVICE AND THE CRACKING CONTINUED UNTIL THE HALF OF THE ARM HOUSING THAT DOES NOT CONTAIN THE SWITCH BROKE COMPLETELY. THIS MOVED ALL THE STRESS TO THE SIDE OF THE ARM HOUSING WITH THE SWITCH AND THE HOUSING BROKE AT THE WEAKEST LOCATION, WHERE THERE IS A HOLE IN THE ARM HOUSING TO MOUNT THE SWITCH. THERE IS ADHESIVE RESIDUE EXTENDING OVER THE CRACK BY THE SWITCH THAT INDICATES THE CUSTOMER TRIED TO HOLD THE ARM TOGETHER WITH TAPE INSTEAD OF TAKING IT OUT OF SERVICE. ROOT CAUSE/PROBABLE ROOT CAUSE: THE CRACKING OF THE ARM HOUSINGS IS A DOCUMENTED ISSUE ADDRESSED ON CAPA004584. IN THIS CASE AFTER THE ARM WAS VISIBLY DAMAGED THE CUSTOMER CONTINUED TO USE IT UNTIL IT FAILED COMPLETELY. FAILLURE CONFIRMED: YES. INVESTIGATION RESULT CODE: NEURO SBU/PHYSICAL DAMAGE. CLOSURE RATIONALE: COMPLAINT VERIFIED, CAPA INIATED OR ALREADY OPEN.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT (REF NATUS COMPLAINT# (B)(4). CAPA004584 ADDRESSES THE HIGH FAILURE RATE WITH NICIVIEW ARMS. 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) NICVIEW HAZARD ID LINE B2, SEVERITY 3 - REMOTE, RISK LEVEL MODERATE. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOESN'T DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY HAS NOT CHANGED. A DHR 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 SERVICE REPAIR INVESTIGATIONS WILL BE CONDUCTED DURING THE REPAIR PROCESS AND TREND DATA WILL BE REVIEWED PER (B)(4). INSTALL DATE: AUG-27-2018. AFFECTED PRODUCT HAS BEEN RETURNED FOR EVALUATION - AWAITING INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    ARM, SHORT (31" = 80CM) ASSY. THE CUSTOMER REPORTED THAT A CAMERA ASSIGNED TO A PATIENT FELL BUT DIDN'T FALL ON THE PATIENT. THE ARM BROKE IN TWO NEAR THE ON/OFF SWITCH. NO INJURIES.

    Description of Event or Problem · 0

    ARM, SHORT (31" = 80CM) ASSY. THE CUSTOMER REPORTED THAT A CAMERA ASSIGNED TO A PATIENT FELL BUT DIDN'T FALL ON THE PATIENT. THE ARM BROKE IN TWO NEAR THE ON/OFF SWITCH. NO INJURIES.

    Description of Event or Problem · 0

    ARM, SHORT (31" = 80CM) ASSY. THE CUSTOMER REPORTED THAT A CAMERA ASSIGNED TO A PATIENT FELL BUT DIDN'T FALL ON THE PATIENT. THE ARM BROKE IN TWO NEAR THE ON/OFF SWITCH. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725191 NICVIEW NICVIEW FWC NATUS MEDICAL INCORPORATED ARM-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown