BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARM SENSOR, 30-DAY BED SENSOR PAD

    MDR report key: 16811821 · Received April 25, 2023

    Report

    Report Number
    2182318-2023-00030
    Event Type
    Injury
    Date Received
    April 25, 2023
    Report Date
    March 27, 2023
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    KMI
    UDI-DI
    10190676004376
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE TIDI REGULATORY COMPLIANCE MANAGER RECEIVED AN EMAIL FROM THE FDA ORIGINAL LETTERS STATING THAT THE FDA RECEIVED A MEDICAL DEVICE REPORT FROM A REPORTER WHO ELECTED NOT TO BE IDENTIFIED CONCERNING THE TIDI 8283 BED SENSOR PAD. THIS EVENT IS REPORTED SOLELY ON THE MEDWATCH INFORMATION PROVIDED BY THE FDA. AN INVESTIGATION OF SIMILAR COMPLAINTS REVEALED SEVERAL POTENTIAL CAUSES, INCLUDING DAMAGES TO EITHER THE ALARM SENSOR RECEPTACLE OR THE SENSOR RJ-11 CLIP. DAMAGE TO THE SENSOR RECEPTACLE CAN CAUSE THE PINS INSIDE TO BECOME STUCK DOWN, EITHER TRIGGERING NO ALARM OR FALSE ALARM. IT CAN ALSO CAUSE THE SENSOR CABLE TO NOT HAVE A SECURE FIT WITH THE RECEPTACLE, ALLOWING FOR MOVEMENT TO AFFECT THE FUNCTION. LIKEWISE WITH DAMAGE TO THE SENSOR CABLE CLIP. OTHER CAUSES, SUCH AS CORROSION AND MOISTURE DAMAGE, ARE ALSO A POSSIBILITY. A DEVICE HISTORY RECORD (DHR) OF THE AFFECTED LOT NUMBER DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. NO NCRS WERE IDENTIFIED. THE UNIT PASSED ALL VERIFICATION TESTING AND MET MANUFACTURING SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION. WITHOUT THE RETURN OF THE DEVICE REPORTED ISSUE COULD NOT BE CONFIRMED. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NUMBER 2023-00348 MDR REPORT NUMBER MW5114480.

    Description of Event or Problem · 0

    WE RECEIVED A FDA MEDWATCH COMPLAINT ON PRODUCT # 8283 FROM UNKNOWN USER. IT IS STATED THAT A POSEY BED ALARM WAS PLACED ON A TRAUMA PATIENT AND THE ALARM DID NOT SOUND WHEN THE PATIENT TRIED TO EXIT THE BED. THIS RESULTED IN A FALL FROM THE BED. IT IS DESIGNATED AS A SERIOUS INJURY. THE REPORTER HAS DECIDED TO REMAIN ANONYMOUS. DATE OF THE REPORT IS (B)(6) 2023. REPORTED INITIALLY BY BRENDA AMMONETTE REG/COMP MANAGER. 920-279-7744 OR E-MAIL AT [email protected]. LOT # 2144T217. INFORMATION GIVEN WAS EXTREMELY LIMITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492771 ALARM SENSOR, 30-DAY BED SENSOR PAD MONITOR, BED PATIENT KMI TIDI PRODUCTS, LLC 8283 2144T217 10190676004376

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention