BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATIC AIR CUSHION

    MDR report key: 15013732 · Received July 14, 2022

    Report

    Report Number
    15013732
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 20, 2022
    Manufacturer
    MOLNLYCKE MANUFACTURING US, LLC
    Product Code
    FMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WAFFLE CHAIR CUSHION FOUND DEFLATED FOLLOWING PATIENT USE. THE CHAIR CUSHION IS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASES THE RISK FOR HOSPITAL ACQUIRED PRESSURE INJURIES. THUS, IT HAS THE POTENTIAL FOR SKIN INTEGRITY IMPAIRMENT. NO PATIENT INJURY NOTED FOR THIS CASE. MANUFACTURER RESPONSE FOR WAFFLE CUSHION, BRAND NOT PROVIDED, PER SITE REPORTER. REPORTED TO MEDLINE AND MOLYLNCKE FOR PRODUCT REPLACEMENT.

    Description of Event or Problem · 0

    WAFFLE CHAIR CUSHION FOUND DEFLATED FOLLOWING PATIENT USE. THE CHAIR CUSHION IS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASES THE RISK FOR HOSPITAL ACQUIRED PRESSURE INJURIES. THUS, IT HAS THE POTENTIAL FOR SKIN INTEGRITY IMPAIRMENT. NO PATIENT INJURY NOTED FOR THIS CASE. MANUFACTURER RESPONSE FOR WAFFLE CUSHION, (BRAND NOT PROVIDED) (PER SITE REPORTER): REPORTED TO MEDLINE AND MOLYLNCKE FOR PRODUCT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469264 STATIC AIR CUSHION PROTECTOR, SKIN PRESSURE FMP MOLNLYCKE MANUFACTURING US, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown