SMARTMONITOR 2 PROFESSIONAL SERIES MONITOR/OXIMETER

Description of Event or Problem

THE MFR RECEIVED MEDWATCH REPORT # 4400480000-2014-8003 WHICH STATES: "6-8 NEW MONITORS WERE PURCHASED FOR THE NICU AND THE EXPECTATION WAS THAT THE ALARMS WOULD BE SIMILAR TO THE OLDER VERSION OF THE DEVICE. WE HAVE RECEIVED COMPLAINTS FROM THE NURSING STAFF THAT THESE NEWER MODELS DO NOT ALARM LOUD ENOUGH. A CASE NUMBER WAS GIVEN TO OUR FACILITY WHEN WE CALLED IN THE COMPLAINT TO THE MFR. THE MFR'S ENGINEER REPORTED TO OUR BIOMED THAT THERE WAS NOT A WAY TO ADJUST THE VOLUME ALARM SETTING. ANOTHER CALL WAS MADE TO THE MFR AND WE WERE GIVEN A SECOND CASE NUMBER. THE MFR'S ENGINEER TOLD THE FACILITY THERE IS NOT A WAY TO ADJUST THE SETTING". THE MEDWATCH REPORT DOES NOT INDICATE THAT THERE WAS ANY TYPE OF PT IMPACT.

Additional Manufacturer Narrative

(B)(4). THE MFR IS WORKING WITH THE USER FACILITY IN ORDER TO ARRANGE FOR RETURN OF A DEVICE FOR FURTHER EVAL. THE CUSTOMER REPORTED TO THE MFR VIA TELEPHONE THAT SHE DOESN'T FEEL THAT THE ALARM IS MALFUNCTIONING, BUT IS JUST A LOWER VOLUME THAN HER TEAM IS USED TO EXPERIENCING. THE DEVICES LISTED ON THE MEDWATCH ARE FINISHED GOOD NUMBER (FGN) (B)(4) SMART MONITOR 2 PS HOSPITAL ALARM UNITS. THE HOSPITAL ALARM UNITS HAVE AN ALARM MODULE THAT IS QUIETER THAN THE STANDARD SMART MONITOR 2PS UNIT (FGN (B)(4)). THE HOSPITAL ALARM UNITS WERE DESIGNED FOR CUSTOMERS WHO ARE FOCUSED ON DEVELOPMENTAL CARE PRINCIPALS AND WANT TO MINIMIZE NOISE IN THE NICU. THESE DEVICES HAVE A MINIMUM REQUIRED ALARM OUTPUT OF 70 DECIBELS, WHILE THE STANDARD SMART MONITOR 2PS UNIT MUST BE AT LEAST 75 DECIBELS. THE CUSTOMER STATED THAT SHE DIDN'T KNOW THAT THERE WERE 2 DIFFERENT HOSPITAL ALARMS AND IS UPSET THAT SHE WANT TOLD THIS WHEN SHE ORDERED THE DEVICES. WHILE THERE CURRENTLY IS NO EVIDENCE SUPPORTING THAT A DEVICE MALFUNCTION OCCURRED, THIS HAS NOT BEEN CONFIRMED BY EVAL OF A DEVICE. THEREFORE, THIS REPORT IS BEING FILED WITH LIMITED INFO IN ORDER TO MEET THE 30 DAY MDR DEADLINE. A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. ADDITIONAL INFO: SERIAL# (B)(4). K061256.