BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINAIR

    MDR report key: 1991180 · Received February 11, 2011

    Report

    Report Number
    1625774-2011-00011
    Event Type
    Death
    Date Received
    February 11, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 14, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, PRIOR TO DELIVERY TO THE HEALTH CARE FACILITY, THE BED WENT THROUGH NORMAL QUALITY CONTROL TESTING AND MET SPECIFICATIONS, INCLUDING THE SIDERAILS AND CUSHIONS. THE BED WAS NOT RETURNED TO KCI BUT IT WAS INSPECTED. ON (B)(6) 2011, FOLLOWING THE REPORTED INCIDENT, THE BED WAS INSPECTED AND ALL FOUR-SIDE RAILS FUNCTIONED PROPERLY AND NO DAMAGE TO SIDE RAILS WERE OBSERVED. THE CUSHIONS WERE ALSO EXAMINED FOR PROPER INFLATION PRESSURE AND ALL SECTIONS WERE FOUND OPERATING AS DESIGNED. KINAIR MEDSURG LABELING AVAILABLE IN PRINT AND ONLINE, CAUTIONS "WHETHER AND HOW TO USE SIDE RAILS OR OTHER RESTRAINTS ARE DECISIONS THAT SHOULD BE BASED ON EACH PATIENT'S INDIVIDUAL NEEDS AND SHOULD BE MADE BY THE PATIENT AND THE PATIENT'S FAMILY, PHYSICIAN AND CAREGIVERS, WITH FACILITY PROTOCOLS IN MIND. CONSIDER NOT ONLY THE CLINICAL AND OTHER NEEDS OF THE PATIENT BUT ALSO THE RISKS OF SERIOUS OR FATAL INJURY FROM FALLING OUT OF BED AND FROM PATIENT ENTRAPMENT IN OR AROUND THE SIDE RAILS, RESTRAINTS OR OTHER ACCESSORIES" AND TO "MONITOR RESTRAINED PATIENTS FREQUENTLY TO GUARD AGAINST PATIENT ENTRAPMENT AND MIGRATION." FOR A DESCRIPTION OF ENTRAPMENT HAZARDS, REFER TO FDA SAFETY ALERT DATED AUGUST 23, 1995, THE (B)(4) EVENT ALERT #27, DATED SEPTEMBER 6, 2002, AND OTHER INFORMATION REFERENCED AT HTTP://WWW.KCIL.COM/PRODUCTS/FDASAFETYALERT. KINAIR MEDSURG PULSE HAS AN EXIT ALARM BUTTON FEATURE WHERE A 10% OR MORE DECREASE IN PATIENT WEIGHT IS DETECTED WHEN ACTIVATED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE RISK MANAGER: ON (B)(6) 2010, THE PATIENT WAS PLACED ON THE KINAIR MEDSURG PULSE FOR MULTIPLE AREAS OF SKIN BREAKDOWN. THE PATIENT WAS ALERT BUT CONFUSED AT TIMES. ON (B)(6) 2011, AT APPROXIMATELY 1438, THE PATIENT WAS FOUND ENTRAPPED IN ZONE 4, WITH HIS LEGS ON THE FLOOR ON THE RIGHT SIDE OF THE SURFACE AND UPPER BODY FACING OUTWARD. BOTH SIDE RAILS AT THE HEAD OF THE BED WERE NOTED TO BE IN THE UP POSITION. THERE WAS NO REPORT OF ANY RESUSCITATION EFFORTS BY THE FACILITY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011, THE RISK MANAGER REPORTED THAT THE PATIENT WAS WEARING A BED EXIT DEVICE PROVIDED BY THE FACILITY, BUT THE DEVICE HAD NOT ALARMED BECAUSE, THE PATIENT WAS LAYING ON IT AT THE TIME OF THE INCIDENT. ALSO, THE KINAIR MEDSURG PULSE BED EXIT ALARM FEATURE/SCALE WAS NOT IN USE AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINAIR IOQ KCI USA, INC. MEDSURG PULSE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CLOPIDOGREL BISULFATE: 75 MG DAILY| CIPROFLOXIN: 500 MG EVERY 6 HOURS| CARVEDILOL: 3.125 MG TWICE A DAY| ALTEPASE 2.8 MG/2.6 MG| FAMOTIDINE: 20 MG AT BEDTIME| AMIODARONE: 200 MG EVERY DAY