SmartMonitor 2 w/o Modem 4002Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI B0364002), received between Dec 10, 2015 and Nov 26, 2018 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Defective Alarm” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K011597); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2018Solder Joint Fracture; Solder Joint Fracture

  A USER FACILITY REPORTED THAT THE NURSE CALL JACK ON THE MONITOR WAS NOT FUNCTIONING PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102283 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CONTACTED CIRCADIANCE TO REPORT THAT A SMART MONITOR 2 INFANT APNEA MONITOR AND AN OXYGEN CYLINDER HAD BEEN INVOLVED IN A "FLASH FIRE". THE FOLLOWING TEXT IS COPIED FROM THE SUBMISSION FORM RECEIVED FROM (B)(6): "THIS DEVISE (SIC) WAS USED AT THE SAME TIME AN OXYGEN TANK EMITTED A FLASH FIRE. THE MOTHERS (SIC) FOOT WAS BURNED NO INJURY TO THE CHILD OR ANYONE ELSE. THE APNEA MONITOR CONTINUED TO WORK WITHOUT INTERRUPTION. PLEASE DO A FULL INVESTIGATION OF EQUIPMENT WITH A DETAILED REPORT OF THE FUNCTIONALITY OF APNEA MONITOR." A FOLLOW UP CALL TO (B)(6) REVEALED THAT THE PATIENT'S MOTHER EXPERIENCED A SECOND DEGREE BURN ON HER FOOT AND REQUIRED TREATMENT AT A HOSPITAL. CIRCADIANCE IS NOT AWARE OF WHETHER OR NOT THE MOTHER WAS ADMITTED TO THE HOSPITAL OR IF TREATMENT WAS ADMINISTERED IN THE EMERGENCY DEPARTMENT. THERE IS NO REPORTED INJURY TO THE INFANT PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: Apnea

  MAUDE report 7833862 ↗
• MalfunctionMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFANT WAS REPORTED TO HAVE BEEN MONITORED BY THE DEVICE IN QUESTION. THE PARENTS REPORTED TO THE DURABLE MEDICAL EQUIPMENT PROVIDER THAT THE BABY WAS FOUND BLUE AND THE MONITOR WAS NOT ALARMING. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED. THERE WAS NO PERMANENT INJURY REPORTED TO CIRCADIANCE AND THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED BACK HOME THE DAY AFTER ADMISSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7486197 ↗
• MalfunctionMar 29, 2016Device Alarm System; Defective Alarm; Device Alarm System; Defective Alarm

  CIRCADIANCE, LLC RECEIVED A CUSTOMER COMPLAINT ALLEGING THAT A SMARTMONITOR 2 UNIT WOULD NOT TURN ON. THE UNIT WAS SENT BACK TO CIRCADIANCE, LLC FOR EVALUATION. UPON INSPECTION OF THE DEVICE, THE CUSTOMER COMPLAINT OF THE DEVICE NOT TURNING ON WAS NOT CONFIRMED. DURING THE EVALUATION, IT WAS ALSO DETERMINED THAT THE DEVICE HAD A FAULTY ALARM MODULE. THE CUSTOMER STATED THAT THE DEVICE WAS IN USE AT THE TIME; HOWEVER, NO PATIENT OR USER HARM WAS ALLEGED OR HAD OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5532976 ↗
• MalfunctionDec 10, 2015Device Alarm System; Defective Alarm

  CIRCADIANCE, (B)(4) RECEIVED A CUSTOMER COMPLAINT ON (B)(6) 2015 WHERE IT WAS ALLEGED THAT A SMARTMONITOR 2 UNIT WAS NOT PRODUCING AN AUDIBLE ALARM. THE UNIT WAS SENT BACK TO CIRCADIANCE, (B)(4). UPON INSPECTION OF THE DEVICE, IT WAS DETERMINED THAT THE DEVICE WAS PRODUCING AN AUDIBLE ALARM; HOWEVER, THE ALARM SOUND WAS DISTORTED. THE CUSTOMER STATED THAT THE DEVICE WAS IN USE AT THE TIME THE PROBLEM WAS DISCOVERED AND NO PATIENT OR USER HARM WAS ALLEGED OR HAD OCCURRED. THE ALARM MODULE HAS BEEN RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW UP REPORT. THE SMARTMONITOR 2 DEVICE HAS PROVISIONS TO ALLOW THE USER TO DETECT FAILURE OF THE AUDIBLE ALARM. SPECIFICALLY, THE USERS ARE INSTRUCTED THAT THE AUDIBLE ALARM WILL ANNUNCIATE EVERY TIME THAT THE MONITOR IS TURNED ON ALLOWING THE USER TO VERIFY ALARM FUNCTIONALITY PRIOR TO PLACING THE DEVICE INTO SERVICE. ADDITIONALLY, USERS ARE INSTRUCTED TO PERFORM A FULL DEVICE CHECKOUT BY FOLLOWING THE PUBLISHED SMARTMONITOR 2 CHECKOUT PROCEDURE BETWEEN USES ON DIFFERENT PATIENTS OR AT LEAST ANNUALLY IF THE MONITOR HAS NOT BEEN IN USE. THE STEPS OF THE CHECKOUT PROCEDURE FULLY V

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5284898 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011597. One submission often covers many models, so check the product and lot details in each record.

• Z-1411-2009 · Apr 23, 2009 · Terminated
  SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environm
• Z-1093-2008 · Oct 15, 2007 · Terminated
  Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.