A CALL/COMPLAINT WAS RECEIVED INDICATING THE "PATIENT SLID TO THE FLOOR AND THE ALARM DID NOT SOUND". THERE WERE NO INJURY REPORTED. THE WORK ORDER COULD NOT BE REVIEWED BECAUSE THE FINISHED GOOD LOT NUMBER WAS NOT REPORTED. THE SAMPLE WAS RECEIVED AND EVALUATED BY QUALITY CONTROL. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE MANUFACTURING FACILITY. THE SAMPLE HAS BEEN RETURNED TO THE MANUFACTURING FACILITY FOR FURTHER EXAMINATION. THIS INVESTIGATION IS ONGOING AT THIS TIME. WE WILL PROVIDE A FOLLOW UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
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Patient 1
QUALITY ISSUE DETAILS. DATE OF OCCURRENCE: (B)(6) 2018. WHEN DID QUALITY ISSUE OCCUR? DURING USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? HEALTH PROFESSIONAL. WAS A MEDICAL PROCEDURE INVOLVED? NO. NAME OF MEDICAL PROCEDURE: NOT APPLICABLE, DID THE QUALITY ISSUE CAUSE A DELAY IN THE MEDICAL PROCEDURE? NOT APPLICABLE. DETAILED DESCRIPTION OF QUALITY ISSUE: THE ALARM WAS USED FOR A PATIENT AND THE RN REPORTED USING THE NORMAL PROCESS. THE PATIENT SLID TO THE FLOOR AND THE ALARM DID NOT SOUND. WHEN THE ALARM WAS TESTED LATER IT SEEMED TO WORK APPROPRIATELY. THE RN IS CERTAIN THAT THE ALARM HAD BEEN PROPERLY SET AND HAD MALFUNCTIONED. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY ACTUAL USE. HOW WAS THE PRODUCT BEING USED? USED TO MONITOR PATIENTS AT RISK OF FALLING OUT OF THE CHAIR. WAS IT THE INITIAL USE OF THE PRODUCT? NO. WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY DEROYAL? NO. WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT? YES. PLEASE DESCRIBE CONNECTED EQUIPMENT TYPE, SETTINGS, ETC.: USED WITH OUR CHAIR SENSOR (M2200-CP) HAS THE END USER NOTIFIED THE MANUFACTURER OF THE OTHER DEVICES USED IN CONJUNCTION WITH OR CONNECTED TO THE PRODUCT? YES. OUTCOME DETAILS. OUTCOME(S) ATTRIBUTED TO QUALITY ISSUE: NONE. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: NONE. WAS THE INCIDENT REPORTED TO THE FDA? NO. DETAILED DESCRIPTION OF OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY ADDITIONAL TREATMENT/INTERVENTION REQUIRED: NONE.