BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED 300

    MDR report key: 17661808 · Received August 31, 2023

    Report

    Report Number
    9710055-2023-00611
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Report Date
    August 31, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF H4 MANUFACTURE DATE DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H4 MANUFACTURE DATE: 2019-09-30. CORRECTED H4 MANUFACTURE DATE: 2019-10-01. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. BASED ON PHOTOGRAPHIC EVIDENCE THE CRACKS IN THE UPPER PART OF THE CASE OCCURRED WITH POSSIBILITY OF MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. BASED ON AN INFORMATION GATHERED, PWD300 - ALUMINIUM TOP COVER (ARD368337998) WAS REPLACED, AND DEVICE IS BACK IN USAGE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT DUE TO THE CRACKS IN THE COVER, WITH POSSIBILITY OF MISSING PARTICLES. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT UPON THE EVENT OCCURRENCE. ACCORDING TO THE INFORMATION GATHERED, THE ISSUE WAS DISCOVERED BY GETINGE TECHNICIAN DURING PREVENTIVE MAINTENANCE. A REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO THE INVESTIGATED ISSUE REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. COMPARING THE NUMBER OF COMPLAINED DEVICES TO THE NUMBER OF SOLD DEVICES WORLDWIDE, WE CONCLUDE THAT THE FAILURE RATIO IS MODERATE. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERTS AT THE MANUFACTURING SITE. AS THEY STATED, ALL MAQUET SAS PRODUCTS COMPLY WITH: IEC 60601-1 ED. 2.0 & ED. 3.0 GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE. IEC 60601-2-41 PARTICULAR REQUIREMENTS FOR THE SAFETY OF SURGICAL LUMINAIRES AND LUMINAIRE FOR DIAGNOSIS. DISINFECTION PRODUCTS TEST: MAQUET SAS DESCRIBED HOW TO PERFORM THE MATERIAL RESISTANCE TEST IN THE WORKING INSTRUCTION REF. (B)(4). THE FOLLOWING DISINFECTION PRODUCTS ARE TESTED: SURFA¿SAFE, ISOPROPYL ALCOHOL, INCIDIN PRO, VIRKON. THE AIM OF THESE TESTS IS TO DETECT ANY INCOMPATIBILITY WITH DISINFECTANT. AS PER SUBJECT MATTER EXPERTS¿ EXPERTISE, THE INVOLVED ZONE WAS PROBABLY EXPOSED AND THE EDGES DAMAGED CORRESPONDS TO A RETENTION ZONE. THESE FACTS INDICATE THAT CLEANING AGENT RESIDUES MAY HAVE A NEGATIVE REACTION ON PLASTIC SURFACES AND LEAD TO ITS DEGRADATION. THE CONCENTRATION OF CHEMICAL PRODUCTS, THE STAGNATION OF SUBSTANCE RESIDUES ON THE SURFACES ARE PROBABLY THE MAIN FACTORS LEADING TO THE DETERIORATION OF SURFACES. TO AVOID DEGRADATION OF THE SHELL IT IS RECOMMENDED TO RESPECT THE CONTACT TIME OF CLEANING AGENT WITH THE DEVICE AND TO WIPE IT WITH A DRY CLOTH AND TO MAKE SURE NO LIQUID RESIDUE IS LEFT ON THE DEVICE AFTER CLEANING (IFU 01581 EN 09 EXTRACT, PAGE 35-38). USER MANUAL FOR POWERLED (IFU 01581 EN 09 EXTRACT, PAGES 20-22) ALSO MENTIONS TO PERFORM DAILY INSPECTION IN ORDER TO CHECK THE PRESENCE OF PAINT CHIP, IMPACT MARKS OR OTHER DAMAGE. TO PREVENT SIMILAR INCIDENTS, IT IS RECOMMENDED TO RESPECT THE CLEANING INSTRUCTIONS AND AVOID: PROLONGED EXPOSURE TO DETERGENTS AND DISINFECTANTS SOLUTIONS. HIGH CONCENTRATIONS OF CLEANING AGENTS. PROHIBITED PRODUCTS. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    ON (B)(6), 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. BASED ON PHOTOGRAPHIC EVIDENCE THE CRACKS IN THE UPPER PART OF THE CASE OCCURRED WITH POSSIBILITY OF MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438300 POWERLED 300 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568330933

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown