INTELLICUFF STANDALONE

Additional Manufacturer Narrative

HAMILTON MEDICAL AGS REFERENCE: (B)(4). HAMILTON MEDICAL AGS CONCLUSION: INVESTIGATION ONGOING.

Description of Event or Problem

HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: INTELLICUFF SWITCHED OFF WHILE IT WAS USING ON PATIENT. ADDITIONAL DEVICE NEEDED. NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

Additional Manufacturer Narrative

HAMILTON MEDICAL AGS REFERENCE: (B)(4); HAMILTON MEDICAL AGS CONCLUSION: THE COMPLAINANT REPORTED THAT THE INTELLICUFF SWITCHED OFF DURING USE ON A PATIENT. NO LOGFILES WERE AVAILABLE FOR ANALYSIS. BASED ON THE INVESTIGATION AND AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE WAS DEPLETION OR WEAR OF THE INTERNAL BATTERIES. THE COMPLAINANT LATER CONFIRMED: ¿THE INTELLICUFF WASN¿T CONNECTED TO THE HAMILTON-C6. THE TWO INTERNAL BATTERIES WERE EMPTY. THE CUSTOMER REPLACED THESE TWO BATTERIES. BACK IN USE.¿ THEREFORE, THE REPORTED DEVICE SHUTDOWN CAN BE ATTRIBUTED TO EMPTY INTERNAL BATTERIES, AND NORMAL DEVICE FUNCTION WAS RESTORED AFTER BATTERY REPLACEMENT. NO FURTHER DEVICE-RELATED MALFUNCTION WAS IDENTIFIED. NO FURTHER INFORMATION RECEIVED. CASED IS CONSIDERED CLOSED.