BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-TECH

    MDR report key: 2120458 · Received May 9, 2011

    Report

    Report Number
    1929691-2011-00004
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    December 17, 2010
    Report Date
    May 26, 2011
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, (B)(6) RECEIVED THE EQUIPMENT AS RETURNED BY THE COMPLAINANT. DURING (B)(6) TEST, THE FOLLOWING WAS FOUND: THE MICRO-TECH INFORMER MATE MODEL # 81781 WAS WORKING ACCORDING TO THE MANUFACTURER SPECIFICATIONS. THE MICRO-TECH PAD MODEL #82710 (LOT # 30110) WAS WORKING ACCORDING TO MANUFACTURER SPECIFICATIONS. HOWEVER, THE MAT WAS FOLDED TO FIT IN RETURN BOX BY THE COMPLAINANT. PER THE INSTRUCTIONS ON THE MAT, "DO NOT FOLD OR CREASE - STORE FLAT." SUBSEQUENT TO (B)(6) TESTING, (B)(6) WAS CONTACTED BY (B)(6) ABOUT THE ALLEGED INCIDENT ON (B)(6) 2011. THE RISK MANAGER AND DIRECTOR OF NURSING STATED THAT THEIR INTERNAL REPORT INDICATED THAT A MONITOR WAS IN USE WITH THE PATIENT AT THE TIME OF THE INCIDENT, BUT THAT THE MONITOR REPORTEDLY DID NOT ALARM DURING THE INCIDENT. HOWEVER, THE REPORT ALSO SAID THAT THE MONITOR DID ALARM JUST AFTER THE INCIDENT, WHEN THE RESIDENT WAS BEING RETURNED TO THE BED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(6) REPORTED THAT HIS MOTHER HAD FALLEN IN (B)(6) 2010 WHILE RECEIVING CARE AT (B)(6). (B)(6) STATED THAT THE NURSE ON STAFF SAID THE MONITOR DID NOT ALARM WHEN THE FALL OCCURRED. (B)(6) STATED THAT THE BED X-RAY TAKEN BY (B)(6) HAD INDICATED THAT SHE WAS FINE. AFTER RETURNING HOME FOR A COUPLE OF DAYS, (B)(6) TOOK HIS MOTHER TO A DIFFERENT HOSPITAL WHERE THEY DISCOVERED THAT SHE HAD BROKEN HER PELVIS IN 2 PLACES. (B)(6) CONTACTED (B)(6) ON (B)(6) 2011 AND SHIPPED THE EQUIPMENT BACK ON (B)(6) 2011 FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-TECH INFORMER MATE AND PAD KMI STANLEY SECURITY SOLUTIONS, INC. 81781, 82710 30110 (82710)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization