BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC ONDASPACE SPRING ARM 15-16 KG RAL9016

    MDR report key: 18361734 · Received December 20, 2023

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    9710055-2023-00970
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 29, 2023
    Report Date
    December 20, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF D1 BRAND NAME, D2A PRODUCT CODE., D4 VERSION OF MODEL #, D4 CATALOG # D4 UNIQUE IDENTIFIER (UDI), H4 MANUFACTURE DATE AND H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D2A PRODUCT CODE. FXR, CORRECTED D2A PRODUCT CODE. FSY, PREVIOUS D1 BRAND NAME: DC ONDASPACE SPRING ARM 15-16 KG RAL9016, CORRECTED D1 BRAND NAME: NA, PREVIOUS D4 VERSION OF MODEL # ARD567801151, CORRECTED D4 VERSION OF MODEL # ARD515031550A, PREVIOUS D4 CATALOG # ARD567801151, CORRECTED D4 CATALOG # NONE, PREVIOUS D4 UNIQUE IDENTIFIER (UDI) #: N/A, CORRECTED D4 UNIQUE IDENTIFIER (UDI) #: (B)(4), PREVIOUS H4 MANUFACTURE DATE: 2018-09-14, CORRECTED H4 MANUFACTURE DATE: 2018-09-17, PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO, CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES, PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER, CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A, PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER, CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - DC ONDASPACE SPRING ARM 15-16 KG RAL9016. IT WAS STATED THE TOP AND BOTTOM STOPPER PINS CAME OFF FROM MONITOR SPRING ARM AND THERE WAS A RISK OF THE ARM COMING OFF. MOREOVER, IT WAS FOUND, THE MONITOR SIDE COVER HAS COME OFF. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES OR PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY IN CASE OF REOCCURRENCE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS. A ROOT CAUSE ANALYSIS WAS CONDUCTED BY THE SUBJECT MATTER EXPERT. AS STATED, IT WAS REPORTED THAT THE SPRING ARM SUPPORTING THE MONITOR COULD NOT LOWER (LOCKED IN THE UP POSITION) AND THAT THE MONITOR'S SIDE COVER HAD COME OFF. ACCORDING TO THE INFORMATION PROVIDED, THE SPRING ARM HAS PROBABLY LOST ITS ABILITY TO MOVE UP AND DOWN DUE TO AN ANOMALY IN THE INTERNAL MECHANISM, WHICH COULD BE A DEFORMATION, A BREAK OR THE DISPLACEMENT OF A COMPONENT. THE DETACHMENT OF THE MONITOR'S SIDE COVER WAS PROBABLY CAUSED BY A COLLISION. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    EVENT SITE TELEPHONE: (B)(6). 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 29TH NOVEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - DC ONDASPACE SPRING ARM 15-16 KG RAL9016. IT WAS STATED THE TOP AND BOTTOM STOPPER PINS CAME OFF FROM MONITOR SPRING ARM AND THERE WAS A RISK OF THE ARM COMING OFF. MOREOVER IT WAS FOUND, THE MONITOR SIDE COVER HAS COME OFF. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES OR PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY IN CASE OF REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050065 DC ONDASPACE SPRING ARM 15-16 KG RAL9016 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD515031550A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown