Description of Event or Problem · 1
ON (B)(4) 2012, SALTER LABS CUSTOMER SERVICE RECEIVED A COMPLAINT FROM DIRECT CUSTOMER (B)(6). (NOT PATIENT) REGARDING AN INCIDENT IN (B)(6) INVOLVING OXYGEN TUBING REPORTEDLY DISCONNECTING FROM THE MANOMETER (BRAND UNKNOWN), CAUSING THE PATIENT TO FEEL AS THOUGH THEY WERE "SUFFOCATING." THE HEAD OF QUALITY SYSTEMS AT SALTER LABS CONTACTED A REPRESENTATIVE FROM DIRECT (B)(6) TO INQUIRE ON THE PATIENT'S STATUS AND TO CLARIFY WHETHER ANY MEDICAL INTERVENTION WAS REQUIRED IN THIS INCIDENT. ON (B)(6) 2012, THE REPRESENTATIVE FROM (B)(6) REPORTED THAT THE PATIENT'S SATURATION LEVEL REPORTEDLY DROPPED TO 86% DURING THE INCIDENT BUT IT IS UNCLEAR WHAT THE PATIENT'S SATURATIONS WERE PRIOR TO THE TUBING DISCONNECTING FROM THE MANOMETER. THE TUBE WAS REPORTEDLY CHANGED TO A DIFFERENT BRAND (BRAND UNKNOWN) AND THE BRAND OF THE MANOMETER INVOLVED IS ALSO UNKNOWN. THE PATIENT WAS GIVEN ANXIOLYTICS REPORTEDLY BECAUSE THE PATIENT BECAME ANXIOUS DUE TO FEELING AS THOUGH THEY WERE SUFFOCATING. IT IS IMPORTANT TO NOTE THAT THE PRODUCT IN QUESTION HAS NOT BEEN RETURNED TO SALTER LABS FOR EVALUATION AND WITHOUT KNOWING THE MODEL OR BRAND OF MANOMETER USED DURING THE INCIDENT, IT IS IMPOSSIBLE TO CONFIRM THE FAILURE/ DETERMINE THE ROOT CAUSE OF THE FAILURE. FURTHER, THE SALTER LABS PRODUCT IN QUESTION HAS NOT BEEN RETURNED TO DATE NOR IS THE LOT NUMBER KNOWN, SO IT IS THEREFORE, IMPOSSIBLE TO VERIFY THE DEVICE HISTORY RECORD FOR THIS PRODUCT. SHOULD THE PRODUCT BE RETURNED FOR ANALYSIS IN THE FUTURE, SALTER LABS WILL FILE A FOLLOW UP MDR AT THAT TIME; HOWEVER, THIS IS CONSIDERED A FINAL REPORT.