BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINAIR MEDSURG PULSE BED

    MDR report key: 1548237 · Received November 17, 2009

    Report

    Report Number
    1548237
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Date of Event
    November 13, 2009
    Report Date
    November 17, 2009
    Manufacturer
    KCI, INC.
    Product Code
    INX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS A FRESH POST-OP PT FROM HER MUSCLE FLAP AND DEBRIDEMENT SURGERY TO HER BUTTOCKS AREA, WHEN HER KCI CLINICAL ADVANTAGE THERMAPULSE SPECIALTY BED DEFLATED UNDERNEATH HER. PT HAD BEEN BACK FROM SURGERY FOR APPROXIMATELY 30 MINUTES. CERTIFIED NURSE AIDE (CNA) WAS AT BEDSIDE WHEN THIS OCCURRED. PER THE CNA NOTHING HAD BEEN UNPLUGGED OR TURNED OFF ON THE BED WHEN THE DEFLATION OCCURRED. THE CNA QUICKLY CHECKED THE BED AND TRIED TO RESUME THE INFLATION. CNA REPORTED THE BED SOUNDED LIKE IT TRIED TO "POWER UP" AND INFLATE BUT IT DID NOT. THE CNA CALLED FOR ASSISTANCE. THE PT HAD PILLOWS PLACED UNDER HER UNTIL STAFF COULD TRANSFER HER TO A SPECIALTY CHAIR. BED WAS SWAPPED OUT FOR ANOTHER KCI SPECIALTY BED AND THEN PT WAS TRANSFERRED TO ANOTHER BED. ORIGINAL BED TAKEN OUT OF ROOM AND WAS EXAMINED BY NURSING STAFF, FACILITIES BED STAFF PERSONNEL, AND TRANSPORT STAFF (WHO ASSISTS WITH KCI EQUIPMENT). THE BED WAS NOT ABLE TO BE REINFLATED BY ANY STAFF. KCI NOTIFIED. RN DID REASSESS THE PATIENT UPON DEFLATION, AND UPON TRANSFER TO THE CHAIR AND BACK TO ANOTHER BED TO ENSURE PT DID NOT HAVE ANY DISRUPTION OR INJURY TO HER SURGICAL SITE. DRESSING AND JP DRAIN INTACT. NO CHANGE IN VITAL SIGNS THROUGHOUT THE EVENT. STAFF ESTIMATED THIS OCCURRED WITHIN A 15 MINUTE PERIOD. RN ALSO NOTIFIED THE SURGEON. NO FURTHER ORDERS AT THE TIME. BED TO BE SENT BACK TO KCI FOR EVALUATION. PT PRESENTLY DOING WELL. MANUFACTURER RESPONSE (AS PER REPORTER) FOR SPECIALTY BED, KCI CLINICAL ADVANTAGE THERMAPULSEREP AWARE OF ISSUE. BED REMOVED FROM OUR FACILITY AND RETURNED TO KCI FOR EVALUATION PURPOSES.

    Description of Event or Problem · 1

    PATIENT WAS A FRESH POST-OP PT FROM HER MUSCLE FLAP AND DEBRIDEMENT SURGERY TO HER BUTTOCKS AREA, WHEN HER KCI CLINICAL ADVANTAGE THERMAPULSE SPECIALTY BED DEFLATED UNDERNEATH HER. PT HAD BEEN BACK FROM SURGERY FOR APPROXIMATELY 30 MINUTES. CERTIFIED NURSE AIDE (CNA) WAS AT BEDSIDE WHEN THIS OCCURRED. PER THE CNA NOTHING HAD BEEN UNPLUGGED OR TURNED OFF ON THE BED WHEN THE DEFLATION OCCURRED. THE CNA QUICKLY CHECKED THE BED AND TRIED TO RESUME THE INFLATION. CNA REPORTED THE BED SOUNDED LIKE IT TRIED TO "POWER UP" AND INFLATE BUT IT DID NOT. THE CNA CALLED FOR ASSISTANCE. THE PT HAD PILLOWS PLACED UNDER HER UNTIL STAFF COULD TRANSFER HER TO A SPECIALTY CHAIR. BED WAS SWAPPED OUT FOR ANOTHER KCI SPECIALTY BED AND THEN PT WAS TRANSFERRED TO ANOTHER BED. ORIGINAL BED TAKEN OUT OF ROOM AND WAS EXAMINED BY NURSING STAFF, FACILITIES BED STAFF PERSONNEL, AND TRANSPORT STAFF (WHO ASSISTS WITH KCI EQUIPMENT). THE BED WAS NOT ABLE TO BE REINFLATED BY ANY STAFF. KCI NOTIFIED. RN DID REASSESS THE PATIENT UPON DEFLATION, AND UPON TRANSFER TO THE CHAIR AND BACK TO ANOTHER BED TO ENSURE PT DID NOT HAVE ANY DISRUPTION OR INJURY TO HER SURGICAL SITE. DRESSING AND JP DRAIN INTACT. NO CHANGE IN VITAL SIGNS THROUGHOUT THE EVENT. STAFF ESTIMATED THIS OCCURRED WITHIN A 15 MINUTE PERIOD. RN ALSO NOTIFIED THE SURGEON. NO FURTHER ORDERS AT THE TIME. BED TO BE SENT BACK TO KCI FOR EVALUATION. PT PRESENTLY DOING WELL. MANUFACTURER RESPONSE (AS PER REPORTER) FOR SPECIALTY BED, KCI CLINICAL ADVANTAGE THERMAPULSEREP AWARE OF ISSUE. BED REMOVED FROM OUR FACILITY AND RETURNED TO KCI FOR EVALUATION PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINAIR MEDSURG PULSE BED BED, HOSPITAL THERAPY INX KCI, INC. 40030B *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR