SMART MONITOR 2 PS
Received Aug 26, 2014
Report 1218950-2014-07405 · MDR key 4330095
Device
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4) A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PMA 510(K): K032403, K061256.
Description of Event or Problem
PHILIPS HEALTHCARE RECEIVED A COMPLAINT OF A BATTERY DRAINING TOO QUICKLY. THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT OBSERVED DURING THE REPAIR EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CTR, HOWEVER, A FINDING OF "FAULTY ALARM MODULE" NOT RELATED TO THE CUSTOMER'S COMPLAINT WAS OBSERVED. THE SECONDARY ALARM DID ALARM AS EXPECTED BUT WE ARE REPORTING THE ON THE FAULTY ALARM MODULE PREVENTATIVELY. THE MODULE WILL BE SENT TO THE SUPPLIER AND A F/U REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.