SmartMonitor 2 w/ Modem 4003Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI B0364003), received between Dec 3, 2015 and Aug 29, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2018No Audible Alarm; No Audible Alarm

  A USER FACILITY CONTACTED CIRCADIANCE ON (B)(6) 2018 AND REPORTED THAT THE AUDIBLE ALARM IN THE MONITOR WAS NOT FUNCTIONING. THE MONITOR WAS NOT BEING USED WITH A PATIENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7826643 ↗
• MalfunctionAug 12, 2016Device Alarm System; Device Alarm System

  CIRCADIANCE, LLC RECEIVED CUSTOMER COMPLAINT ALLEGATION ON (B)(6) 2016 DETAILING A PRODUCT ISSUE ASSOCIATED WITH A SMARTMONITOR 2 DEVICE. THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO ALARM DURING THE FUNCTIONAL SELF-TEST. NO RESULTING EFFECT ON A PATIENT OR POTENTIAL USER HAS BEEN REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5871605 ↗
• MalfunctionJul 6, 2016Device Alarm System; Defective Alarm; Device Alarm System; Defective Alarm

  CIRCADIANCE, LLC RECEIVED CUSTOMER COMPLAINT ALLEGATION ON (B)(6) 2016 FROM A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER DETAILING AN AUDIBLE ALARM FAILURE ASSOCIATED WITH A SMARTMONITOR 2 DEVICE. THE CUSTOMER REPORTED THAT FAILURE OCCURRED WHEN HOOKING UP THE DEVICE TO THE PATIENT AND THE DEVICE FAILED TO PRODUCE AN AUDIBLE ALARM DURING THE START-UP SELF-TEST DIAGNOSTIC. NO RESULTING EFFECT ON A PATIENT OR POTENTIAL USER HAS BEEN REPORTED. VISUAL ALARM INDICATORS WERE REPORTEDLY FUNCTIONING BOTH AT PATIENT'S HOME AND ON THE SIMULATOR BACK IN THE OFFICE DURING TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5773073 ↗
• InjuryDec 3, 2015Adverse Event Without Identified Device or Use Problem

  A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER CONTACTED THE MANUFACTURER REPORTING AN ALLEGED EVENT IN WHICH A CAREGIVER REPORTED THE "APNEA ALARM DIDN'T SOUND/LIGHT UP DURING AN APPARENT LIFE THREATENING EVENT." THE CAREGIVER REPORTED TAKING THE INFANT TO THE HOSPITAL. THE DME STATED THE INCIDENT OCCURRED "CLOSE TO WHEN THE MONITOR WAS LAST USED". THE SPECIFIC DATE AND TIME OF THE EVENT IS UNKNOWN. THE MANUFACTURER RECEIVED THE APNEA MONITOR FOR EVALUATION AND DETERMINED THE DEVICE DID NOT MALFUNCTION. THE ALLEGATION THAT THE MONITOR DID NOT ALARM COULD NOT BE CONFIRMED. THE APNEA MONITOR WAS VISUALLY EXAMINED AND TESTED BY THE MANUFACTURER USING A SIMULATOR IN ACCORDANCE WITH RELEASED SERVICE PROCEDURES. THE TESTING PROCESS USED IN SERVICE IS THE SAME TEST SEQUENCE USED DURING THE MANUFACTURING PROCESS FOR NEW MONITORS. THE APNEA MONITOR DETECTED AND ALARMED APPROPRIATELY FOR ALL SIMULATED EVENTS GENERATED DURING THE SERVICE TEST SEQUENCE. DURING THE REPAIR EVALUATION, IT WAS DISCOVERED THE UNIT NEEDED A NEW MODEM PCA; HOWEVER, ALL CONDITIONS FOR ALARMS WERE VERIFIED TO PERFORM TO SPECIFICATIONS. THE MODEM PCA HAS NO IMPACT ON THE MONITORING CAPABILITY OF THE SMARTMONITOR 2 AND IS O

  Patient problems: Apnea

  MAUDE report 5262952 ↗

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.