BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD

    MDR report key: 14565424 · Received June 1, 2022

    Report

    Report Number
    3003768277-2022-00262
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    March 9, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054226
    PMA / PMN Number
    K162859
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THE REPORTED EVENT FURTHER. THE REPORTED SITUATION WITH THE MATTRESS SLIPPING IS NOT CONSIDERED A MALFUNCTION. THE MATTRESS IS DESIGNED SO THAT IT IS NOT FIXED TO THE TABLE TOP TO ALLOW REPOSITIONING OF THE MATTRESS ON THE TABLE TOP AND TO NOT COMPROMISE IMAGE QUALITY AND CLEANABILITY OF THE MATTRESS AND TABLETOP. AT ALL TIMES CARE MUST BE TAKEN WHEN POSITIONING THE PATIENT ON AND OFF THE MATTRESS, MAKING SURE THAT IT DOES NOT SLIP. CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS VIA MEDWATCH FORM (REFERENCE: (B)(4)) THAT A PATIENT FELL DURING TRANSFER FROM THE TABLE TO THE CART: 'PATIENT WAS INTUBATED AND BEING TRANSFERRED FOR EXTUBATION ON A CART. ALL FOUR INDIVIDUALS IN THE ROOM WERE ASSISTING WITH A BOARD EXAM TABLE TO CART TRANSFER. WHILE ROLLING THE PATIENT TOWARDS MYSELF, THE TABLE MATTRESS BEGAN TO SHIFT WITH THE PATIENT AND SHE BEGAN TO FALL ON ME. I BRACED MY BODY UP AGAINST HERS AND BRACED MY HIP TO THE EXAM TABLE AND TRIED TO USE MY BODY TO KEEP HER ON THE TABLE. HER HEAD AND SHOULDERS CONTINUED TO FALL OFF THE TABLE TO MY LEFT. AS SHE CONTINUED TO FALL, I WRAPPED BOTH MY ARMS AROUND HER LEGS TO STOP THE FALL. AT THIS POINT, 2 OTHERS WERE ALSO TRYING TO GRAB ONTO HER. SHE CONTINUED TO FALL HEAD AND SHOULDERS OVER HIPS ONTO THE FLOOR. TRAUMATIC EXTUBATION, LACERATION TO HEAD REQUIRING SUTURES, SHE DOES HAVE A NEW RIGHT VOCAL CORD PARESIS. THIS COULD BE RELATED TO HER TRAUMATIC EXTUBATION/RE-INTUBATION, OR POTENTIALLY RELATED TO HER RECENT SCLEROTHERAPY IN THE REGION OF THE RECURRENT LARYNGEAL NERVE. MATTRESS WAS ATTACHED ON TWO AREAS WITH VELCRO. PHILIPS RECEIVED ADDITIONAL INFORMATION REGARDING THE LACERATION AND RIGHT VOCAL CORD PARESIS. THE LACERATION OF 2 CM WAS LOCATED ON THE FOREHEAD AND WAS TREATED WITH 4 SUTURES, THE PATIENT UNDERWENT IMAGING AND WAS ADMITTED TO THE HOSPITAL. THE HOSPITAL STAY WAS PROLONGED BY 3 DAYS. THE PATIENT WAS REFERRED TO THE EARS, NOSE, AND THROAT PHYSICIAN FOR FOLLOW UP TREATMENT FOR THE RIGHT VOCAL CORD PARESIS. THE PRODUCT HAS NOT BEEN RETURNED TO PHILIPS. PICTURES WERE SHARED WITH PHILIPS WHICH SHOWED THAT VELCRO WAS ADDED TO THE TABLETOP AND THE MATTRESS. THIS IS NOT PART OF THE DESIGN. IT IS UNKNOWN IF THE VELCRO MAY HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. PHILIPS HAS INITIATED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462009 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20/20 00884838054226

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R